Community composition, diversity, and metabolism of intestinal microbiota in cultivated European eel (Anguilla anguilla).

PubMed

Huang, Wei; Cheng, Zhiqiang; Lei, Shaonan; Liu, Lanying; Lv, Xin; Chen, Lihua; Wu, Miaohong; Wang, Chao; Tian, Baoyu; Song, Yongkang

2018-05-01

The intestinal tract, which harbours tremendous numbers of bacteria, plays a pivotal role in the digestion and absorption of nutrients. Here, high-throughput sequencing technology was used to determine the community composition and complexity of the intestinal microbiota in cultivated European eels during three stages of their lifecycle, after which the metabolic potentials of their intestinal microbial communities were assessed. The results demonstrated that European eel intestinal microbiota were dominated by bacteria in the phyla Proteobacteria and Fusobacteria. Statistical analyses revealed that the three cultured European eel life stages (elver, yellow eel, and silver eel) shared core microbiota dominated by Aeromonas. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) predictions of metagenome function revealed that the European eel intestinal microbiota might play significant roles in host nutrient metabolism. Biolog AN MicroPlate™ analysis and extracellular enzyme assays of culturable intestinal bacteria showed that the intestinal microbiota have a marked advantage in the metabolism of starch, which is the main carbohydrate component in European eel formulated feed. Understanding the ecology and functions of the intestinal microbiota during different developmental stages will help us improve the effects of fish-based bacteria on the composition and metabolic capacity of nutrients in European eels.

Regulation of medicinal plants for public health--European community monographs on herbal substances.

PubMed

Knöss, Werner; Chinou, Ioanna

2012-08-01

The European legislation on medicinal products also addresses the medicinal use of products originating from plants. The objective of the legislation is to ensure the future existence of such products and to consider particular characteristics when assessing quality, efficacy, and safety. Two categories are defined: i) herbal medicinal products can be granted a marketing authorisation; and ii) traditional herbal medicinal products can be granted a registration based on their longstanding use if they are complying with a set of provisions ensuring their safe use. The Committee on Herbal Medicinal Products (HMPC) was established at the European Medicines Agency (EMA) to provide monographs and list entries on herbal substances and preparations thereof. Meanwhile, approx. 100 monographs have been published, which define a current scientific and regulatory standard for efficacy and safety of herbal substances and herbal preparations used in medicinal products. This harmonised European standard will facilitate the availability and adequate use of traditional herbal medicinal products and herbal medicinal products within the European Union. Consequent labelling shall also enable patients and health care professionals to differentiate medicinal products from other product categories like cosmetics, food supplements, and medical devices. Georg Thieme Verlag KG Stuttgart · New York.

Employees' Organizations and Their Contribution to the Development of Vocational Training Policy in the European Community.

ERIC Educational Resources Information Center

Lemke, Horst

This document includes eight chapters and an appendix that lists abbreviations and trade union organizations at the European Community (EC) level. Chapter 1 identifies the roles of employers, employee organizations or trade unions, and system conditions in the development of vocational training policies in the European community. Chapter 2…

European regulation for therapeutic use of stem cells.

PubMed

Ferry, Nicolas

2017-01-01

The regulation for the use of stem cells has evolved during the past decade with the aim of ensuring a high standard of quality and safety for human derived products throughout Europe to comply with the provision of the Lisbon treaty. To this end, new regulations have been issued and the regulatory status of stem cells has been revised. Indeed, stem cells used for therapeutic purposes can now be classified as a cell preparation, or as advanced therapy medicinal products depending on the clinical indication and on the procedure of cell preparation. Furthermore, exemptions to the European regulation are applicable for stem cells prepared and used within the hospital. The aim of this review is to give the non-specialized reader a broad overview of this particular regulatory landscape.

Self-Regulated Learning in Virtual Communities

ERIC Educational Resources Information Center

Delfino, Manuela; Dettori, Giuliana; Persico, Donatella

2008-01-01

This paper investigates self-regulated learning (SRL) in a virtual learning community of adults interacting through asynchronous textual communication. The investigation method chosen is interaction analysis, a qualitative/quantitative approach allowing a systematic study of the contents of the messages exchanged within online communities. The…

Photovoltaic pilot projects in the European community

NASA Astrophysics Data System (ADS)

Treble, F. C.; Grassi, G.; Schnell, W.

The paper presents proposals received for the construction of photovoltaic pilot plants as part of the Commission of the European Communities' second 4-year solar energy R and D program. The proposed plants range from 30 to 300 kWp and cover a variety of applications including rural electrification, water pumping, desalination, dairy farming, factories, hospitals, schools and vacation centers. Fifteen projects will be accepted with a total generating capacity of 1 MWp, with preference given to those projects involving the development of new techniques, components and systems.

Medical Device Regulation: A Comparison of the United States and the European Union.

PubMed

Maak, Travis G; Wylie, James D

2016-08-01

Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.

The community structure of the European network of interlocking directorates 2005-2010.

PubMed

Heemskerk, Eelke M; Daolio, Fabio; Tomassini, Marco

2013-01-01

The boards of directors at large European companies overlap with each other to a sizable extent both within and across national borders. This could have important economic, political and management consequences. In this work we study in detail the topological structure of the networks that arise from this phenomenon. Using a comprehensive information database, we reconstruct the implicit networks of shared directorates among the top 300 European firms in 2005 and 2010, and suggest a number of novel ways to explore the trans-nationality of such business elite networks. Powerful community detection heuristics indicate that geography still plays an important role: there exist clear communities and they have a distinct national character. Nonetheless, from 2005 to 2010 we observe a densification of the boards interlocks network and a larger transnational orientation in its communities. Together with central actors and assortativity analyses, we provide statistical evidence that, at the level of corporate governance, Europe is getting closer.

76 FR 81359 - European Larch Canker; Expansion of Regulated Areas

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. APHIS-2011-0029] European Larch Canker; Expansion of Regulated Areas AGENCY: Animal and Plant Health... willkommi (Dasycypha), is a serious plant disease caused by a fungus that can kill mature and immature...

The European community and its standardization efforts in medical informatics

NASA Astrophysics Data System (ADS)

Mattheus, Rudy A.

1992-07-01

A summary of the CEN TC 251/4 ''Medical Imaging and Multi-Media'' activities will be given. CEN is the European standardization institute, TC 251 deals with medical informatics. Standardization is a condition for the wide scale use of health care and medical informatics and for the creation of a common market. In the last two years, three important categories-- namely, the Commission of the European Communities with their programs and the mandates, the medical informaticians through their European professional federation, and the national normalization institutes through the European committee--have shown to be aware of this problem and have taken actions. As a result, a number of AIM (Advanced Informatics in Medicine), CEC sponsored projects, the CEC mandates to CEN and EWOS, the EFMI working group on standardization, the technical committee of CEN, and the working groups and project teams of CEN and EWOS are working on the subject. On overview of the CEN TC 251/4 ''Medical Imaging and Multi-Media'' activities will be given, including their relation to other work.

Heterogeneity of the environmental regulation of industrial wastewater: European wineries.

PubMed

Román-Sánchez, Isabel M; Aznar-Sánchez, José A; Belmonte-Ureña, Luis J

2015-01-01

The European legislation of the pollution of industrial wastewater shows a high degree of heterogeneity. This fact implies that there is a market failure with relevant consequences. Within the European Union, each Member State performs a specific transposition of the Water Framework Directive 2000/60. The member states introduce different sanitation fees to correct water pollution. In this paper, the case of the European wine industry is analyzed. It studies the sanitation fees of the five major wine producing countries: France, Italy, Spain, Germany and Portugal. Results show significant differences among the wastewater fees and the study reveals how such heterogeneity leads to relevant market distortions. The research concludes that more homogeneous environmental regulation would promote more sustainable wine production processes with more efficient water management and purification systems, as well as the introduction of cutting edge technologies.

European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health

PubMed Central

Bates, C; Fagerstrom, K; Jarvis, M; Kunze, M; McNeill, A; Ramstrom, L

2003-01-01

Rationale: This statement is an updated version of one released by the same authors in February 2003. The statement was produced to follow up the Royal College of Physicians (RCP) Tobacco Advisory Group report "Protecting smokers, saving lives: the case for a tobacco and nicotine regulatory authority",1 which argued for an evidence based regulatory approach to smokeless tobacco and harm reduction and posed a series of questions that regulators must address in relation to smokeless tobacco. The purpose of this statement is to provide arguments of fact and principle to follow the RCP's report and to outline the public health case for changing existing European Union (EU) regulation in this area. A review of regulation in relation to harm reduction and regulation of tobacco products other than cigarettes is required in Article 11 of EU directive 2001/37/EC,2 and this is a contribution towards forming a consensus in the European public health community about what policy the EU should adopt in the light of this review, or following ongoing legal action that may potentially strike out the existing regulation altogether. Public health case: We believe that the partial ban applied to some forms of smokeless tobacco in the EU should be replaced by regulation of the toxicity of all smokeless tobacco. We hold this view for public health reasons: smokeless tobacco is substantially less harmful than smoking and evidence from Sweden suggests it is used as a substitute for smoking and for smoking cessation. To the extent there is a "gateway" it appears not to lead to smoking, but away from it and is an important reason why Sweden has the lowest rates of tobacco related disease in Europe. We think it is wrong to deny other Europeans this option for risk reduction and that the current ban violates rights of smokers to control their own risks. For smokers that are addicted to nicotine and cannot or will not stop, it is important that they can take advantage of much less hazardous

Emotion Regulation Strategies in European American and Hong Kong Chinese Middle School Children

ERIC Educational Resources Information Center

Wan, Kayan Phoebe; Savina, Elena

2016-01-01

This study explored emotion regulation strategies in middle school European American (N = 54) and Hong Kong Chinese (N = 89) children. Children were presented with scenarios describing a fictitious girl/boy who encountered situations eliciting sadness, anger, and fear. Based on Gross' theory (1998), the survey of emotion regulation strategies was…

The Community Structure of the European Network of Interlocking Directorates 2005–2010

PubMed Central

Heemskerk, Eelke M.; Daolio, Fabio; Tomassini, Marco

2013-01-01

The boards of directors at large European companies overlap with each other to a sizable extent both within and across national borders. This could have important economic, political and management consequences. In this work we study in detail the topological structure of the networks that arise from this phenomenon. Using a comprehensive information database, we reconstruct the implicit networks of shared directorates among the top 300 European firms in 2005 and 2010, and suggest a number of novel ways to explore the trans-nationality of such business elite networks. Powerful community detection heuristics indicate that geography still plays an important role: there exist clear communities and they have a distinct national character. Nonetheless, from 2005 to 2010 we observe a densification of the boards interlocks network and a larger transnational orientation in its communities. Together with central actors and assortativity analyses, we provide statistical evidence that, at the level of corporate governance, Europe is getting closer. PMID:23894318

International Institutions and Domestic Reform: Equal Pay and British Membership in the European Economic Community.

PubMed

Frader, Laura Levine

2018-03-01

Despite having been overlooked in the standard histories of the UK and the European Community, gender politics and gender policies played a significant role in Britain's applications for membership in the EEC in the 1960s. Joining the European Community required that Britain comply with Article 119 on equal pay for equal work. A combination of domestic feminist and labour movement activism, the commitment of unions and parties, and the internationalization of formal commitments to women's rights constituted internal and external pressures for the passage of an Equal Pay Act in 1970. The article argues that the formal legislative commitment to gender pay equality, changing public attitudes towards women's employment, and European membership impacted further domestic social policy reform and slowly began to shift government attitudes towards gender equality.

Building international collaborative capacity: contributions of community psychologists to a European network.

PubMed

García-Ramírez, Manuel; Paloma, Virginia; Suarez-Balcazar, Yolanda; Balcazar, Fabricio

2009-09-01

Europe is in the process of building a more participative, just, and inclusive European Union. The European Social Fund, which is an initiative developed to actively promote multinational partnerships that address pressing social issues, is a good example of the European transformation. This article describes the steps taken to develop and evaluate the activities of an international network promoting collaborative capacity among regional partners involved in the prevention of labor discrimination toward immigrants in three European countries-Spain, Belgium, and Italy. An international team of community psychologists proposed an empowering approach to assess the collaborative capacity of the network. This approach consisted of three steps: (1) establishing a collaborative relationship among partners, (2) building collaborative capacity, and (3) evaluating the collaborative capacity of the network. We conclude with lessons learned from the process and provide recommendations for addressing the challenges inherent in international collaboration processes.

Which lessons can we learn from the European Union legal framework of medicines for the regulation of direct-to-consumer genetic tests?

PubMed

van Hellemondt, Rachèl; Hendriks, Aart; Breuning, Martijn

2012-01-01

The legal framework of the European Union (EU) for regulating access to and supply of direct-to-consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorising the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic tests purchased through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic tests on the European regulatory agenda.

[Management of chemical products and European standards: new classification criteria according to the 1272/2008 (CLP) regulation].

PubMed

Fanghella, Paola Di Prospero; Aliberti, Ludovica Malaguti

2013-01-01

The European Union adopted regulations (EC) 1907/2006 REACH e (EC)1272/2008 CLP, to manage chemicals. REACH requires for evaluation and management of risks connected to the use of chemical substances, while o CLP provides for the classification, labelling and packagings of dangerous substances and mixtures by implementing in the EU the UN Globally Harmonised System of Classification and Labelling applying the building block approach, that is taking on board the hazard classes and categories which are close to the existing EU system in order to maintain the level of protection of human health and environment. This regulation provides also for the notification of the classification and labelling of substances to the Classification & Labelling Inventory established by the European Chemicals Agency (ECHA). Some european downstream regulations making reference to the classification criteria, as the health and safety laws at workplace, need to be adapted to these regulations.

[Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products].

PubMed

Qu, Li-Ping; Zhang, Xiao-Qun; Xiong, Yan; Wang, Yi-Tao; Zou, Wen-Jun

2017-10-01

Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU. Copyright© by the Chinese Pharmaceutical Association.

Tobacco industry strategies for influencing European Community tobacco advertising legislation.

PubMed

Neuman, Mark; Bitton, Asaf; Glantz, Stanton

2002-04-13

Restrictions on tobacco company advertising and sponsorship are effective parts of tobacco control programmes worldwide. Through Council Directive 98/43/EC, the European Community (EC) sought to end all tobacco advertising and sponsorship in EC member states by 2006. Initially proposed in 1989, the directive was adopted in 1998, and was annulled by the European Court of Justice in 2000 following a protracted lobbying campaign against the directive by a number of interested organisations including European tobacco companies. A new advertising directive was proposed in May, 2001. We reviewed online collections of tobacco industry documents from US tobacco companies made public under the US Master Settlement Agreement of 1998. Documents reviewed dated from 1978 to 1994 and came from Philip Morris, R J Reynolds, and Brown and Williamson (British American Tobacco) collections. We also obtained approximately 15,000 pages of paper records related to British American Tobacco from its documents' depository in Guildford, UK. This information was supplemented with information in the published literature and consultations with European tobacco control experts. The tobacco industry lobbied against Directive 98/43/EC at the level of EC member state governments as well as on a pan-European level. The industry sought to prevent passage of the directive within the EC legislature, to substitute industry-authored proposals in place of the original directive, and if necessary to use litigation to prevent implementation of the directive after its passage. The tobacco industry sought to delay, and eventually defeat, the EC directive on tobacco advertising and sponsorship by seeking to enlist the aid of figures at the highest levels of European politics while at times attempting to conceal the industry's role. An understanding of these proposed strategies can help European health advocates to pass and implement effective future tobacco control legislation.

Regulating private human suborbital flight at the international and European level: Tendencies and suggestions

NASA Astrophysics Data System (ADS)

Masson-Zwaan, Tanja; Moro-Aguilar, Rafael

2013-12-01

In the context of the FAST20XX project (Future High-Altitude High-Speed Transport) that started in 2009 under the 7th Framework Programme of the European Union (EU), the authors reexamined the legal status of private human suborbital flight, and researched whether it might be regulated as aviation or as spaceflight. International space law is ambiguous as to accommodating suborbital activities. While some provisions of the UN outer space treaties would seem to exclude them, generally there is not any explicit condition in terms of reaching orbit as a requirement for application. International air law presents equal difficulties in dealing with this activity. The classic definition of "aircraft" as contained in the Annexes to the Chicago Convention does not really encompass the kind of rocket-powered vehicles that are envisaged here. As a result, it is unclear whether the United Nations Committee on the Peaceful Uses of Outer Space (COPUOS), the International Civil Aviation Organization (ICAO), or both could be involved in an eventual international regulation of suborbital flight. In the absence of a uniform international regime, each state has the sovereign right to regulate human suborbital flights operating within its airspace. So far, two practical solutions have been realised or proposed, and will be analyzed. On the one hand, the USA granted power for regulation and licensing over private human suborbital flight to the Office of Commercial Space Transportation of the Federal Aviation Administration (FAA/AST). Subsequent regulations by the FAA have set out a series of requirements for companies that want to operate these flights, enabling a market to develop. On the other side of the Atlantic, both the European Space Agency (ESA) and a group of representatives of the European Aviation Safety Agency (EASA) of the European Union (EU) seem to rather regard this activity as aviation, potentially subject to the regulation and certification competences of EASA

The changes in hazard classification and product notification procedures of the new European CLP and Cosmetics Regulations.

PubMed

de Groot, Ronald; Brekelmans, Pieter; Herremans, Joke; Meulenbelt, Jan

2010-01-01

The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS) is developed to harmonize the criteria for hazard communication worldwide. The European Regulation on classification, labeling, and packaging of substances and mixtures [CLP Regulation (European Commission, EC) No 1272/2008] will align the existing European Union (EU) legislation to the UN-GHS. This CLP Regulation entered into force on January 20, 2009, and will, after a transitional period, replace the current rules on classification, labeling, and packaging for supply and use in Europe. Both old and new classifications will exist simultaneously until 2010 for substances and until 2015 for mixtures. The new hazard classification will introduce new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard (H)-statements, and Precautionary (P)-statements as labeling elements. Furthermore, the CLP Regulation will affect the notification of product information on hazardous products to poisons information centers (PICs). At this moment product notification widely varies in procedures and requirements across EU Member States. Article 45 of the CLP Regulation contains a provision stating that the EC will (by January 20, 2012) review the possibility of harmonizing product notification. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) is recognized as an important stakeholder. For cosmetic products, the new Cosmetics Regulation will directly implement a new procedure for electronic cosmetic product notification in all EU Member States. Both the CLP Regulation and the Cosmetics Regulation will develop their own product notification procedure within different time frames. Harmonization of notification procedures for both product groups, especially a common electronic format, would be most effective from a cost-benefit viewpoint and would be welcomed by PICs.

New trends and challenges in the European regulation of innovative medicines.

PubMed

Enzmann, Harald

2016-10-01

Regulators' marketing authorizations for innovative medicines are linked into a complex process with successive crucial decisions. Objectives and decision criteria of the stakeholders in this process, e.g. health technology assessment (HTA) bodies, payers, physicians and patients, vary and may result not only in different but even mutually exclusive requirements. Reacting to changes in scientific, economic and social demands, European regulatory agencies alter content and format of their assessment procedures and their communication. New diagnostic options (e.g. genotyping and biomarkers) and pharmaceutical innovations (e.g. targeted medicines, nanomedicines) are the scientific drivers of this development. Social drivers are the price and reimbursement decisions by HTA bodies and payers, prerequisites for most patients' access to innovative medicines. The European Medicines Agency's adaptive licensing concept and priority medicines scheme foster the early authorization of innovative medicines. HTA builds on regulators' assessment, with additional requirements and economic components. An intensified exchange between all stakeholders, e.g. in multilateral scientific advice procedures has been initiated. Diminishing the differences in the requirements of regulators and HTA bodies is in the best interest of both patients and the pharmaceutical industry, avoiding duplication of work and accelerating patients' access by early decisions on price and reimbursement. Copyright © 2016 Elsevier Inc. All rights reserved.

Warming shelf seas drive the subtropicalization of European pelagic fish communities.

PubMed

Montero-Serra, Ignasi; Edwards, Martin; Genner, Martin J

2015-01-01

Pelagic fishes are among the most ecologically and economically important fish species in European seas. In principle, these pelagic fishes have potential to demonstrate rapid abundance and distribution shifts in response to climatic variability due to their high adult motility, planktonic larval stages, and low dependence on benthic habitat for food or shelter during their life histories. Here, we provide evidence of substantial climate-driven changes to the structure of pelagic fish communities in European shelf seas. We investigated the patterns of species-level change using catch records from 57,870 fisheries-independent survey trawls from across European continental shelf region between 1965 and 2012. We analysed changes in the distribution and rate of occurrence of the six most common species, and observed a strong subtropicalization of the North Sea and Baltic Sea assemblages. These areas have shifted away from cold-water assemblages typically characterized by Atlantic herring and European sprat from the 1960s to 1980s, to warmer-water assemblages including Atlantic mackerel, Atlantic horse mackerel, European pilchard and European anchovy from the 1990s onwards. We next investigated if warming sea temperatures have forced these changes using temporally comprehensive data from the North Sea region. Our models indicated the primary driver of change in these species has been sea surface temperatures in all cases. Together, these analyses highlight how individual species responses have combined to result in a dramatic subtropicalization of the pelagic fish assemblage of the European continental shelf. © 2014 John Wiley & Sons Ltd.

Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison

PubMed Central

Zeitoun, Jean-David; Lefèvre, Jérémie H.; Downing, Nicholas; Bergeron, Henri; Ross, Joseph S.

2014-01-01

Background The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines. Methods and Findings We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement. Conclusions Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined. PMID:25333986

Regulatory or regulating publics? The European Union's regulation of emerging health technologies and citizen participation.

PubMed

Flear, Mark L; Pickersgill, Martyn D

2013-01-01

'Citizen participation' includes various participatory techniques and is frequently viewed as an unproblematic and important social good when used as part of the regulation of the innovation and implementation of science and technology. This is perhaps especially evident in debates around 'anticipatory governance' or 'upstream engagement'. Here, we interrogate this thesis using the example of the European Union's regulation of emerging health technologies (such as nanotechnology). In this case, citizen participation in regulatory debate is concerned with innovative objects for medical application that are considered to be emergent or not yet concrete. Through synthesising insights from law, regulatory studies, critical theory, and science and technology studies, we seek to cast new light on the promises, paradoxes, and pitfalls of citizen participation as a tool or technology of regulation in itself. As such we aim to generate a new vantage point from which to view the values and sociotechnical imaginaries that are both 'designed-in' and 'designed-out' of citizen participation. In so doing, we show not only how publics (do not) regulate technologies, but also how citizens themselves are regulated through the techniques of participation.

REGULATORY OR REGULATING PUBLICS? THE EUROPEAN UNION'S REGULATION OF EMERGING HEALTH TECHNOLOGIES AND CITIZEN PARTICIPATION

PubMed Central

Flear, Mark L.; Pickersgill, Martyn D.

2013-01-01

‘Citizen participation’ includes various participatory techniques and is frequently viewed as an unproblematic and important social good when used as part of the regulation of the innovation and implementation of science and technology. This is perhaps especially evident in debates around ‘anticipatory governance’ or ‘upstream engagement’. Here, we interrogate this thesis using the example of the European Union's regulation of emerging health technologies (such as nanotechnology). In this case, citizen participation in regulatory debate is concerned with innovative objects for medical application that are considered to be emergent or not yet concrete. Through synthesising insights from law, regulatory studies, critical theory, and science and technology studies, we seek to cast new light on the promises, paradoxes, and pitfalls of citizen participation as a tool or technology of regulation in itself. As such we aim to generate a new vantage point from which to view the values and sociotechnical imaginaries that are both ‘designed-in’ and ‘designed-out’ of citizen participation. In so doing, we show not only how publics (do not) regulate technologies, but also how citizens themselves are regulated through the techniques of participation. PMID:23222171

European Community Respiratory Health Survey calibration project of dosimeter driving pressures.

PubMed

Ward, R J; Ward, C; Johns, D P; Skoric, B; Abramson, M; Walters, E H

2002-02-01

Two potential sources of systematic variation in output from Mefar dosimeters, the system used in the European Community Respiratory Health Survey (ECRHS) study have been evaluated: individual nebulizer characteristics and dosimeter driving pressure. Output variation from 366 new nebulizers produced in two batches for the second ECRHS were evaluated, using a solute tracer method, at a fixed driving pressure. The relationship between dosimeter driving pressure was then characterized and between-centre variation in dosimeter driving pressure was evaluated in an Internet-based survey. A systematic difference between nebulizers manufactured in the two batches was identified. Batch one had a mean+/-SD output of 7.0+/-0.8 mg x s(-1) and batch two, 6.3+/-0.7 mg x s(-1) (p<0.005). There was a wide range of driving pressures generated by Mefar dosimeters as set, ranging between 70-245 kPa, with most outside the quoted manufacturer's specification of 180+/-5%. Nebulizer output was confirmed as linearly related to dosimeter driving pressure (coefficient of determination (R2)=0.99, output=0.0377 x driving pressure-0.4151). The range in driving pressures observed was estimated as consistent with a variation of about one doubling in the provocative dose causing a 20% fall in forced expiratory volume in one second. Systematic variation has been identified that constitutes potentially significant confounders for between-centre comparisons of airway responsiveness in the European Community Respiratory Health Survey, with the dosimeter driving pressure representing the most serious issue. This work confirms the need for appropriate quality control of both nebulizer output and dosimeter driving pressure, in laboratories undertaking field measurements of airway responsiveness. In particular, appropriate data on driving pressures need to be collected and factored into between-centre comparisons. Comprehensive collection of such data to optimize quality control is practicable and has

76 FR 79529 - Community Reinvestment Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

...The OCC, the Board, and the FDIC (collectively, the ``agencies'') are amending their Community Reinvestment Act (CRA) regulations to adjust the asset-size thresholds used to define ``small bank'' or ``small savings association'' and ``intermediate small bank'' or ``intermediate small savings association.'' As required by the CRA regulations, the adjustment to the threshold amount is based on the annual percentage change in the Consumer Price Index.

European emission, fuel quality regs tighten--

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1989-12-18

Emission regulations and fuel quality requirements will tighten as Europe enters the 1990s. The stiffer emission regulations, particularly in those nations in the European Economic Community (EEC), will more closely resemble those already in effect in the U.S. and Japan. Nations not in the EEC, particularly Austria, Switzerland, Norway, Sweden, and Finland, are also formulating rules that adopt the 1983 U.S. emission standards. Rules and tax incentives have also been introduced to encourage the use of unleaded gasoline in EEC member countries. Details of some of the emission rules for both EEC member and non-member countries are discussed.

The European Schools: Perspectives of Parents as Participants in a Learning Community

ERIC Educational Resources Information Center

Martínez, María A.; Hetterschijt, Caroline; Iglesias, Marcos J.

2015-01-01

Within the framework of schools as communities of learning and practice, the purpose of the research upon which this article is based has been to analyze the perceptions of families with respect to the strengths, weaknesses, and challenges of the European Schools. The findings of the research show that parents value highly the existence of the…

Strange Encounters on the Road to Lifelong Learning: The European Economic Community Meets Permanent Education in 1973

ERIC Educational Resources Information Center

Hake, Barry J.

2017-01-01

This paper examines policy formation on education in the European Economic Community during the early 1970s surrounding the 1973 report For a "Community Policy on Education", known as the Janne Report. It examines Community policy-making processes that gave rise to the Janne Report. The text of the Janne Report is analysed with regard to…

The photovoltaic pilot projects of the European Community

NASA Astrophysics Data System (ADS)

Schnell, W.

The Commission of the European Communities has started in 1980 a programme for the design and construction of a series of photovoltaic pilot projects in the range of 30-300 kWp. Virtually all important industries and other development organisations in Europe working on photovoltaic cells and systems are involved in this programme. The different technologies which are being developed concern the modules, the cabling of the array, structure design, storage strategy and power conditioning. The various applications include powering of an island, villages, recreation centres, water desalination and disinfection, powering of radio transmitters, emergency power plants, dairy farm, training school, cooling, water pumping, powering of a solar heated swimming pool and last but not least, hydrogen production.

75 FR 82217 - Community Reinvestment Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

...The OCC, the Board, the FDIC, and the OTS (collectively, the ``agencies'') are amending their Community Reinvestment Act (CRA) regulations to adjust the asset-size thresholds used to define ``small bank'' or ``small savings association'' and ``intermediate small bank'' or ``intermediate small savings association.'' As required by the CRA regulations, the adjustment to the threshold amount is based on the annual percentage change in the Consumer Price Index.

Commission Memorandum on Vocational Training in the European Community in the 1990s.

ERIC Educational Resources Information Center

Commission des Communautes Europeennes (Luxembourg).

As new European Community (EC) objectives become prominent in the coming years, vocational training policy will assume increasing importance. The socioeconomic context of the 1990s will be characterized by an accelerating pace of change and the growing role of intangible capital. New forms of work organization with new requirements for…

Ethical and legal framework and regulation for off-label use: European perspective.

PubMed

Lenk, Christian; Duttge, Gunnar

2014-01-01

For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained.

DTCA of prescription medicines in the European Union: is there still a need for a ban?

PubMed

Poser, Mareen

2010-12-01

The pharmaceutical sector is one of the main markets in the European Union. The consumption of medicines is high and steadily increasing. However, the pharmaceutical market is subject to a wider range of restrictions than almost any other sector. The restrictions mainly apply to information provision and advertising practice within the community. One of the main features in pharmaceutical regulation is the ban on direct-to-consumer advertising (DTCA) of prescription medicines. However, an abolition of the ban is controversial in the European Community, especially as the pharmaceutical industry keeps pleading for its ability to use the highly effective marketing strategy of DTCA to promote prescription medicines to the general public. Such advertising is only allowed in two jurisdictions in the world, New Zealand and the United States. In both systems the impact of DTCA on the consumer and the economy has been subject to research. The outcome of these studies is outlined in this article. Since the European Commission has provided a new proposal to amend the current information practice regarding prescription medicines in 2008 (European Commission, Proposal for a Directive of the European Parliament and of the Council Amending, as Regards Information to the General Public on Medicinal Products Subject to Medical Prescription, Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, COM/2008/0663 final) it is time to examine different options to regulate the provision of information and discuss the need for a ban of DTCA.

Assessment of the smoke-free outdoor regulation in the WHO European Region.

PubMed

Martínez, Cristina; Guydish, Joseph; Robinson, Gillian; Martínez-Sánchez, Jose María; Fernández, Esteve

2014-07-01

The aim of this study is to assess the level of protection of secondhand smoke in outdoor locations among countries belonging to the WHO European Region. This cross-sectional study measures the level of protection provided by laws in outdoor locations. A protocol to evaluate the outdoor smoke-free legislation was developed according to the recommendations provided by the WHO Guidelines for implementing smoke-free outdoor places. For each law 6 main sectors and 28 outdoor locations were evaluated. 68 laws from 48 countries were reviewed, totally assessing 1758 locations. Overall 3.1% of the locations specified 100% smoke-free outdoor regulation without exceptions, 2.5% permitted smoking in designated outdoor areas, 37.5% allowed smoking everywhere, and 56.9% did not provide information about how to deal with smoking in outdoor places. In the Education sector 17.8% of the laws specified smoke-free outdoor regulation, mainly in the primary and secondary schools. Three pioneering laws from recreational locations and two from general health facilities specified 100% outdoor smoke-free regulation. Outdoor smoke-free policies among countries belonging to the WHO European Region are limited and mainly have been passed in the primary and secondary schools, which protect minors from the hazards of secondhand smoke in educational settings. Copyright © 2014 Elsevier Inc. All rights reserved.

[European Community Respiratory Health Survey in Adults (ECRHS)].

PubMed

Heinrich, J; Richter, K; Frye, C; Meyer, I; Wölke, G; Wjst, M; Nowak, D; Magnussen, H; Wichmann, H E

2002-05-01

The European Community Respiratory Health Survey (ECRHS) was the first study to assess the geographical variation in asthma, allergy, and allergic sensitization in adults using the same instruments and definitions. The database of the ECRHS includes information from approximately 140 000 individuals aged 20 - 44 years from 22 countries. The aim of this review is to summarize the results of the ECRHS and to present the specific contribution of the German centers in Hamburg and Erfurt. The prevalence ranged from 2.0 - 11.9 % for asthma, 9.5 - 40.9 % for allergic rhinitis, 4.0 - 32.0 % for wheeze, 3.4 - 27.9 % for bronchial hyperreactivity, and 16.2 - 44.5 % for allergic sensitisation against common aeroallergens. Although the prevalence of these atopic disorders were found to be consistently higher for the Hamburg center compared to the Erfurt center, strong regional differences in the prevalences were also found within several other European countries. Overall Europe, the lowest prevalences were seen in the Eastern and Middle European countries with the center Erfurt, followed by the Mediterranean region. The highest prevalences were reported for all English speaking centers. Strong geographic variation was reported for medication for asthma. Asthma seems to be undertreated in several countries. Environmental exposures and in particular indoor factors, and exposures at the workplace are playing a major role for asthma in adulthood. Furthermore, protective effects on atopy were found for exposures to pets (dogs) and a large number of siblings in early childhood. In conclusion, the ECRHS has shown that the prevalence of asthma varies widely. The fact that the geographical pattern is consistent with the distribution of atopy and bronchial responsiveness supports the conclusion that the geographical variations in the prevalence of asthma are true and likely due to environmental factors.

Three years of paediatric regulation in the European Union.

PubMed

Olski, Thorsten M; Lampus, Simona F; Gherarducci, Giulia; Saint Raymond, Agnes

2011-03-01

To investigate whether the Paediatric Regulation has already succeeded in addressing the needs of the paediatric population both quantitatively with respect to paediatric development plans and trials, and qualitatively with respect to the content of the plans. The Paediatric Regulation No 1901/2006 entered into force in Europe on 26 January 2007, with the aim to improve the development of medicinal products, to address the lack of age-appropriate formulations and to provide information on efficacy, safety and dosing for the paediatric population. The Regulation requires applications for marketing authorisations to be accompanied by either a product-specific waiver or a paediatric investigation plan, to be agreed by the Paediatric Committee (PDCO) of the European Medicines Agency (EMA). A retrospective analysis of the applications for Paediatric Investigation Plans (PIPs) and Waivers submitted to the EMA, from 2007 until end of 2009, was performed. The content of scientific opinions adopted by the Paediatric Committee was compared to the proposals submitted by industry, and the paediatric clinical trials registered in the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database were examined. An increasing paediatric medicine development can be expected following the adoption of this legal framework. The highest number of PIPs was in the fields of endocrinology (13.4%), oncology (11%) and infectious (10.8%) and cardiovascular diseases (7.1%), but most therapeutic areas now benefit from paediatric development. A large number of PIPs include measures for the development of age-appropriate formulations (23%), and most include studies on dosing, efficacy and safety to cover the respective paediatric subsets, including the mostly neglected neonates (26%). In many proposals (38%), however, the PDCO had to request major modifications to the proposed PIPs to ensure that the results will meet the needs, in particular by requesting better methodology. The

[Marketing of medicinal products in the European Community. The Mutual Recognition and Decentralised Procedures].

PubMed

Bachmann, Peter

2008-07-01

The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.

Pupil Exchange in the European Community Venice Colloquium (October 24-28, 1977). Collection Studies. Education Series No. 5.

ERIC Educational Resources Information Center

Commission des Communautes Europeennes (Luxembourg).

This publication contains the papers of the Venice Colloquium held in October, 1977 by educators from European countries to discuss the topic of visits and exchanges for pupils. There are seven chapters. Chapter one discusses the context and objectives of the colloquium. Chapter two describes pupil visits and exchanges in the European community.…

[Good for your health? An analysis of the requirements for scientific substantiation in European health claims regulation].

PubMed

Todt, Oliver; Luján, José Luis

2016-06-01

To identify the various types of evidence, as well as their relative importance in European health claims regulation, in order to analyze the consequences for consumer protection of the requirements for scientific substantiation in this regulation. Qualitative analysis of various documents relevant to the regulatory process, particularly as to the implications of the standards of proof for the functional food market, as well as consumer behavior. European regulation defines a hierarchy of evidence that turns randomized controlled trials into a necessary and sufficient condition for health claim authorizations. Consumer protection can be interpreted in different manners. High standards of proof protect consumers from false information about the health outcomes of functional foods, while lower standards lead to more, albeit less accurate information about such outcomes being available to consumers.

The 'European Alliance Against Depression (EAAD)': a multifaceted, community-based action programme against depression and suicidality.

PubMed

Hegerl, Ulrich; Wittmann, Meike; Arensman, Ella; Van Audenhove, Chantal; Bouleau, Jean-Hervé; Van Der Feltz-Cornelis, Christina; Gusmao, Ricardo; Kopp, Maria; Löhr, Cordula; Maxwell, Margaret; Meise, Ulrich; Mirjanic, Milan; Oskarsson, Högni; Sola, Victor Perez; Pull, Charles; Pycha, Roger; Ricka, Regula; Tuulari, Jyrki; Värnik, Airi; Pfeiffer-Gerschel, Tim

2008-01-01

Action programmes fostering partnerships and bringing together regional and national authorities to promote the care of depressed patients are urgently needed. In 2001 the 'Nuremberg Alliance Against Depression' was initiated as a community-based model project within the large-scale 'German Research Network on Depression and Suicidality' (Kompetenznetz 'Depression, Suizidalität'). The 'Nuremberg Alliance Against Depression' was an action programme, conducted in the city of Nuremberg (500,000 inhabitants) in 2001/2002, addressing four intervention levels (Hegerl et al. Psychol Med 2006;36:1225). Based on the positive results of the Nuremberg project (a significant reduction of suicidal behaviour by more than 20%) 18 international partners representing 16 different European countries established the 'European Alliance Against Depression' (EAAD) in 2004. Based on the four-level approach of the Nuremberg project, all regional partners initiated respective regional intervention programmes addressing depression and suicidality. Evaluation of the activities takes place on regional and international levels. This paper gives a brief overview of the background for and experiences with the EAAD. It describes the components of the programme, provides the rationale for the intervention and outlines the current status of the project. The aim of the paper is to disseminate information about the programme's potential to reduce suicidal behaviour and to provide examples of how European community-based 'best practice' models for improving the care of depressed patients and suicidal persons can be implemented using a bottom-up approach. EAAD is mentioned by the European commission as a best practice example within the Green Paper 'Improving the mental health of the population: Towards a strategy on mental health for the European Union' (European Commission 2005).

To What Extent Do Teachers in European Countries Differ in Their Professional Community Practices?

ERIC Educational Resources Information Center

Lomos, Catalina

2017-01-01

Within comparative school effectiveness research facilitated by large-scale data across countries, this article presents the results of the testing for measurement invariance of the latent concept of Professional Community (PC) across 23 European countries and more than 35,000 teachers in secondary schools. The newly proposed Multiple-Group Factor…

Agriculture, Communities, and New Social Movements: East European Ruralities in the Process of Restructuring

ERIC Educational Resources Information Center

Gorlach, Krzysztof; Lostak, Michal; Mooney, Patrick H.

2008-01-01

This paper examines the usefulness of the new social movements (NSMs) paradigm in the changing context of East European post-communist societies and their agricultural systems and rural communities. Starting with statements formulated in Western sociology in the context of Western democratic societies about NSMs as a protest against modernity, the…

European regulations and their impact on tissue banking.

PubMed

Tatarenko, Alina

2006-01-01

Extensive CoE-EU cooperation ensures coherence and complementarities between the principles of the CoE guides which can be regarded as recommendations on best practice, and the technical requirements of the EU directives which set out legally binding requirements. This means that the same standards now exist throughout European continent. Having a common set of standards facilitates cooperation between different healthcare systems, especially in cases of emergencies, and the export-import issues. Adoption of the same quality management and traceability systems helps to minimise the risks and prevent disease transmissions. It reassures patients who undergo treatments outside of their countries. The tissue establishments need to introduce technical and structural changes to adhere to the new regulations which ultimately results in saving and improving of lives of many patients.

The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

PubMed

Lemaire, François; Marchenay, Brigitte; Chassany, Olivier; Barthélémy, Philippe; Bouzzagou, Mohamed; Comet, Denis; Delval, Cécile; Dubray, Claude; Fouret, Cécile; Frija-Orvoen, Elisabeth; Gambotti, Laetitia; Lamarque, Véronique; d'Orsay, Geneviève; Plattner, Valérie; Sibenaler, Claire; Roux, Jacques; Thoby, Frédérique

2015-01-01

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency. © 2015 Société Française de Pharmacologie et de Thérapeutique.

Life cycle environmental impacts of vacuum cleaners and the effects of European regulation.

PubMed

Gallego-Schmid, Alejandro; Mendoza, Joan Manuel F; Jeswani, Harish Kumar; Azapagic, Adisa

2016-07-15

Energy efficiency of vacuum cleaners has been declining over the past decades while at the same time their number in Europe has been increasing. The European Commission has recently adopted an eco-design regulation to improve the environmental performance of vacuum cleaners. In addition to the existing directive on waste electrical and electronic equipment (WEEE), the regulation could potentially have significant effects on the environmental performance of vacuum cleaners. However, the scale of the effects is currently unknown, beyond scant information on greenhouse gas emissions. Thus, this paper considers for the first time life cycle environmental impacts of vacuum cleaners and the effects of the implementation of these regulations at the European level. The effects of electricity decarbonisation, product lifetime and end-of-life disposal options are also considered. The results suggest that the implementation of the eco-design regulation alone will reduce significantly the impacts from vacuum cleaners (37%-44%) by 2020 compared with current situation. If business as usual continued and the regulation was not implemented, the impacts would be 82%-109% higher by 2020 compared to the impacts with the implementation of the regulation. Improvements associated with the implementation of the WEEE directive will be much smaller (<1% in 2020). However, if the WEEE directive did not exist, then the impacts would be 2%-21% higher by 2020 relative to the impacts with the implementation of the directive. Further improvements in most impacts (6%-20%) could be achieved by decarbonising the electricity mix. Therefore, energy efficiency measures must be accompanied by appropriate actions to reduce the environmental impacts of electricity generation; otherwise, the benefits of improved energy efficiency could be limited. Moreover, because of expected lower life expectancy of vacuum cleaners and limited availability of some raw materials, the eco-design regulation should be

Drug evaluation in children 10years after the European pediatric regulation current challenges and perspectives.

PubMed

Élie, Valery; Leroux, Stéphanie; Kaguelidou, Florentia; Jacqz-Aigrain, Evelyne

2018-04-01

The European pediatric regulation, that entered into force in June 2007 with the objectives to improve the health of children in Europe, dramatically changed the regulatory environment of paediatric drug evaluation in Europe. The recent 10years European medicines agency (EMA) report showed that the number of paediatric trials increased and that 238 new medicines and indications for use in children were authorised in the EU. However, results remain constrated and futur developments require european collaborations beween all experts in developmental pharmacology, drug evaluation and trial conduct, training, all aspects already considered in different EU paediatric programs. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Empowering European communities to improve natural resource management for human well-being: the OPPLA web portal & communities of practice

NASA Astrophysics Data System (ADS)

Metzger, M.; Brown, C.; Pérez-Soba, M.; Rounsevell, M.; Verweij, P.; Delbaere, B.; Cojocaru, G.; Saarikoski, H.; Harrison, P.; Zellmer, K.

2014-12-01

The ecosystem services concept is seen by many as a useful paradigm to support decision-making at the complex interface between science, policy and practice. However, to be successful, it requires a strong willingness for collaboration and joint understanding. In support of this aspiration, OPPLA is being developed as a web portal to enable European communities to better manage ecosystems for human well-being and livelihoods. OPPLA will provide access to a variety of online resources such as tools, case studies, lessons learned, videos, manuals and training and educational materials. It will also provide expert forums and spaces for discussions between researchers, practitioners and decision makers. Hence a critical aspect of the success of OPPLA is the co-evolution of communities of practice. An example of a community of practice is the recently launched Ecosystem Services Community - Scotland (ESCom-Scotland; escomscotland.wordpress.com). ESCom-Scotland aims to support better management of Scotland's natural resources by helping to establish a community of practice between individuals and groups involved in the science, policy and practice behind sustainable ecosystem management. It aspires to encourage the sharing of ideas, increase collaboration and to initiate a support network for those engaging with the ecosystem services concept and it will use the OPPLA resources to support these activities. OPPLA is currently at the developmental stage and was instigated by two large European Commission funded research projects: OPERAs (www.operas-project.eu) and OpenNESS (www.openness-project.eu), with a combined budget of ca. €24m. These projects aim to improve understanding of how ecosystem services contribute to human well-being in different social-ecological systems. Research will establish whether, how and under what conditions the ecosystem services concept can move beyond the academic domain towards practical implementation in support of sustainable ecosystem

Assisted suicide: Models of legal regulation in selected European countries and the case law of the European Court of Human Rights.

PubMed

Grosse, Claudia; Grosse, Alexandra

2015-10-01

This paper presents three different models of the legal regulation of assisted suicide in European countries. First, the current legal regime governing assisted suicide in the Netherlands is described where both euthanasia and assisted suicide have been legalised. This section also includes some empirical data on euthanasia and assisted-suicide practices in the Netherlands, as well as a comparison with the current legal legislation in Belgium and Luxembourg. Next, Switzerland is presented as a country where euthanasia is punishable by law but assisted suicide is legally allowed, provided it is not carried out with selfish motives. This section also focuses on the assisted-suicide-related case law of the Swiss Federal Supreme Court and the European Court of Human Rights. Last, the current legal situation regarding assisted suicide in Austria and Germany is described. While the Austrian Penal Code explicitly prohibits assisted suicide, assistance with suicide is not specifically regulated by the German Penal Code. However, medical doctors are not allowed to assist suicides according to the professional codes of conduct drawn up by the German medical associations under the supervision of the health authorities. © The Author(s) 2014.

75 FR 35686 - Community Reinvestment Act Regulation Hearings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-23

... a financial institution's performance under the Community Reinvestment Act (CRA). The purpose of the... authority when examining financial institutions to encourage such institutions to help meet the credit needs... information on CRA regulations and Interagency Examination Procedures are available on the Federal Financial...

[Regulation of food supplements in the European Union and its member states. Part I].

PubMed

Petrenko, A S; Ponomareva, M N; Sukhanov, B P

2014-01-01

The article discusses aspects of the regional (the European Union) and national (European countries) regulation of food supplements. The definition of the supplement category is given. The contemporary issues of nutrition in developed countries are discussed, and the essential role of food supplements in the diet is emphasized. In particular, the use of vitamins, minerals, botanicals and their chemical constituents in food supplements as well as the issue of setting maximum daily limits are discussed. The positive lists of vitamins, minerals and their chemical modifications are presented. The paper also outlines aspects of supplement safety, requirements for their labelling and pre-market notification procedure.

Species-specific effects of Asian and European earthworms on microbial communities in Mid-Atlantic deciduous forests

USDA-ARS?s Scientific Manuscript database

Earthworm species with different feeding, burrowing, and/or casting behaviors can lead to distinct microbial communities through complex direct and indirect processes. European earthworm invasion into temperate deciduous forests in North America has been shown to alter microbial biomass in the soil ...

[Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products].

PubMed

Chabannon, Christian; Sabatier, Florence; Rial-Sebbag, Emmanuelle; Calmels, Boris; Veran, Julie; Magalon, Guy; Lemarie, Claude; Mahalatchimy, Aurélie

2014-05-01

Regulation (EC) n° 1394/2007 from the European Parliament and the Council describes a new category of health products termed « Advanced Therapy Medicinal Products » (ATMPs). ATMPs derive from cell engineering, tissue engineering or genetic manipulations, and can in some instances be combined with medical devices. ATMPs are distributed and administered to patients, after biotechnology or pharmaceutical companies have obtained a marketing authorization that is granted by the European Commission on the basis of the European Medicines Agency (EMA) assessment. Seven years after the publication of the regulation, few of these therapies have received a marketing authorization, and even fewer have met commercial success, suggesting that a number of medical and economic issues still need to be sorted out in order to achieve sustainability in this field. The coexistence of three sets of rules for three categories of health products that are biologically and medically related - ATMPs, ATMPs produced under the hospital exemption rule, and cell therapy products (CTPs) (a specific legal category in France) that have long been used in hematopoietic cell transplantation - constitutes a complex regulatory framework. This situation raises significant issues for historical as well as emerging operators in this moving field that are discussed thereafter. © 2014 médecine/sciences – Inserm.

Regulations applicable to plant food supplements and related products in the European Union.

PubMed

Silano, Vittorio; Coppens, Patrick; Larrañaga-Guetaria, Ainhoa; Minghetti, Paola; Roth-Ehrang, René

2011-12-01

This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin. Unlike food supplements, marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States. In fact, currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents. When the EU approach is compared with approaches adopted in some non-European countries to regulate these product categories, major differences become evident.

Limits and regulations for mycotoxins in food and feed.

PubMed

Zmudzki, J; Wiśniewska-Dmytrow, H

2004-01-01

Mycotoxins are natural contaminants whose presence in food- and feedstuffs cannot be completely avoided. Since several mycotoxins have been associated with and implicated in human and animal diseases there is a need to establish maximum levels, guidelines or action levels for them in some kinds of commodities. International and government authorities in many countries have been investing in mycotoxins research and initiating administrative actions for elaboration of legislation and implementing regulatory measures for the control of mycotoxins. Codex Alimentarius Commission is established international legislation on food and feed. In European Union specific limits and regulations for mycotoxins and other contaminants are constructed under the general Codex standards and based on proposal from European Commission. The legal basis for European Commission became available with the framework Council Regulation (EEC) No 315/93. In this paper, legislation regarding maximum levels for certain mycotoxins in food- and feedstuffs in European Community and other countries were reviewed and discussed.

Biosafety evaluation of recombinant live oral bacterial vaccines in the context of European regulation.

PubMed

Favre, Didier; Viret, Jean-François

2006-05-01

Live bacterial vaccines represent a highly valid preventive strategy in the fight against infectious disease. However, the road from research to market is peppered with hurdles, one of which is the requirement for high biosafety characteristics, which the candidate vaccine has to display. In Europe, the European Agency for the evaluation of medicinal products (EMEA) is the relevant authority regulating the licensure of genetically engineered vaccines. For this purpose, the agency may rely on several directives and guidelines defined in the past 15 years. As for live vaccines containing genetically modified organisms (GMOs) susceptible to be released into the environment, Directive 2001/18/EC determines the framework and principles of an environmental risk assessment (ERA) process, the results of which constitute an important section of the vaccine registration package submitted to registration authorities. In this article, we address the implications of current European regulations for the approval of live oral bacterial vaccines with emphasis on the assessment of potential risks associated with environmental release. Biosafety aspects of already registered and some promising live bacterial vaccine strains will be briefly discussed.

Major Educational Development in the Member States of the European Community, January to September 1990.

ERIC Educational Resources Information Center

EURYDICE European Unit, Brussels (Belgium).

Twice a year the Steering Group of EURYDICE, the Education Information Network in the European Community (EC), holds meetings that offer leading educational policymakers the chance to inform their colleagues of the major changes in education policy in their respective member states since the previous meeting. While not an exhaustive or official…

The magnitude and origin of European-American admixture in the Gila River Indian Community of Arizona: a union of genetics and demography.

PubMed Central

Williams, R C; Knowler, W C; Pettitt, D J; Long, J C; Rokala, D A; Polesky, H F; Hackenberg, R A; Steinberg, A G; Bennett, P H

1992-01-01

Complementary genetic and demographic analyses estimate the total proportion of European-American admixture in the Gila River Indian Community and trace its mode of entry. Among the 9,616 residents in the sample, 2,015 persons claim only partial Native American heritage. A procedure employing 23 alleles or haplotypes at eight loci was used to estimate the proportion of European-American admixture, m(a), for the entire sample and within six categories of Caucasian admixture calculated from demographic data, md. The genetic analysis gave an estimate of total European-American admixture in the community of 0.054 (95% confidence interval [CI] .044-.063), while an estimate from demographic records was similar, .059. Regression of m(a) on md yielded a fitted line m(a) = .922md, r = .959 (P = .0001). When total European-American admixture is partitioned between the contributing populations, Mexican-Americans have provided .671, European-Americans .305, and African-Americans .023. These results are discussed within the context of the ethnic composition of the Gila River Indian Community, the assumptions underlying the methods, and the potential that demographic data have for enriching genetic measurements of human admixture. It is concluded that, despite the severe assumptions of the mathematical methods, accurate, reliable estimates of genetic admixture are possible from allele and haplotype frequencies, even when there is little demographic information for the population. PMID:1609790

European Union and Racial Discrimination.

ERIC Educational Resources Information Center

Commission for Racial Equality, London (England).

The European Community (EC) has the power to pass laws based on the Community Treaty. Since 1989, the EC's Commission for Racial Equality has called for an amendment to the European Treaty that would provide basic protection against racial discrimination throughout the EC and legal remedies for those who suffer discrimination. Tracing the history…

Unintended consequences of regulating drinking water in rural Canadian communities: examples from Atlantic Canada.

PubMed

Kot, Megan; Castleden, Heather; Gagnon, Graham A

2011-09-01

Studies that explore social capital and political will [corrected] in the context of safe drinking water provision in [corrected] Canada are limited. This paper presents findings from a study that examines the capacity of rural Canadian communities to attain regulatory compliance for drinking water. Interviews were conducted with water operators and managers in ten rural communities across Atlantic Canada to identify the burden of compliance arising from the implementation of, and adherence to, drinking water regulations. This research identifies the operator as being particularly burdened by regulatory compliance, often resulting in negative consequences including job stress and a strained relationship with the community they serve. Findings indicate that while regulations are vital to ensuring safe drinking water, not all communities have the resources in place to rise to the challenge of compliance. As a result, some communities are being negatively impacted by these regulations, rather than benefit from their intended positive effect. Copyright © 2011 Elsevier Ltd. All rights reserved.

Self-regulated learning and science achievement in a community college

NASA Astrophysics Data System (ADS)

Maslin, (Louisa) Lin-Yi L.

Self-regulated learning involves students' use of strategies and skills to adapt and adjust towards achievement in school. This research investigates the extent to which self-regulated learning is employed by community college students, and also the correlates of self-regulated learning: Is it used more by students in advanced science classes or in some disciplines? Is there a difference in the use of it by students who complete a science course and those who do not? How does it relate to GPA and basic skills assessments and science achievement? Does it predict science achievement along with GPA and assessment scores? Community college students (N = 547) taking a science course responded to the Motivated Strategies for Learning Questionnaire (MSLQ). The scales measured three groups of variables: (1) cognitive strategies (rehearsal, elaboration, organization, and critical thinking); (2) metacognitive self-regulation strategies (planning, monitoring, and self-regulation); and (3) resource management strategies (time and study environment, effort regulation, peer learning, and help-seeking). Students' course scores, college GPA, and basic skills assessment scores were obtained from faculty and college records. Students who completed a science course were found to have higher measures on cumulative college GPAs and assessment scores, but not on self-regulated learning. Self-regulated learning was found not to be used differently between students in the advanced and beginning science groups, or between students in different disciplines. The exceptions were that the advanced group scored higher in critical thinking but lower in effort regulation than the beginning group. Course achievement was found to be mostly unrelated to self-regulated learning, except for several significant but very weak and negative relationships in elaboration, self-regulation, help-seeking, and effort regulation. Cumulative GPA emerged as the only significant predictor of science achievement

Origin and Evolution of European Community-Acquired Methicillin-Resistant Staphylococcus aureus

PubMed Central

Wirth, Thierry; Andersen, Paal S.; Skov, Robert L.; De Grassi, Anna; Simões, Patricia Martins; Tristan, Anne; Petersen, Andreas; Aziz, Maliha; Kiil, Kristoffer; Cirković, Ivana; Udo, Edet E.; del Campo, Rosa; Vuopio-Varkila, Jaana; Ahmad, Norazah; Tokajian, Sima; Peters, Georg; Schaumburg, Frieder; Olsson-Liljequist, Barbro; Givskov, Michael; Driebe, Elizabeth E.; Vigh, Henrik E.; Shittu, Adebayo; Ramdani-Bougessa, Nadjia; Rasigade, Jean-Philippe; Price, Lance B.; Vandenesch, Francois; Larsen, Anders R.; Laurent, Frederic

2014-01-01

ABSTRACT Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) was recognized in Europe and worldwide in the late 1990s. Within a decade, several genetically and geographically distinct CA-MRSA lineages carrying the small SCCmec type IV and V genetic elements and the Panton-Valentine leukocidin (PVL) emerged around the world. In Europe, the predominant CA-MRSA strain belongs to clonal complex 80 (CC80) and is resistant to kanamycin/amikacin and fusidic acid. CC80 was first reported in 1993 but was relatively rare until the late 1990s. It has since been identified throughout North Africa, the Middle East, and Europe, with recent sporadic reports in sub-Saharan Africa. While strongly associated with skin and soft tissue infections, it is rarely found among asymptomatic carriers. Methicillin-sensitive S. aureus (MSSA) CC80 strains are extremely rare except in sub-Saharan Africa. In the current study, we applied whole-genome sequencing to a global collection of both MSSA and MRSA CC80 isolates. Phylogenetic analyses strongly suggest that the European epidemic CA-MRSA lineage is derived from a PVL-positive MSSA ancestor from sub-Saharan Africa. Moreover, the tree topology suggests a single acquisition of both the SCCmec element and a plasmid encoding the fusidic acid resistance determinant. Four canonical SNPs distinguish the derived CA-MRSA lineage and include a nonsynonymous mutation in accessory gene regulator C (agrC). These changes were associated with a star-like expansion into Europe, the Middle East, and North Africa in the early 1990s, including multiple cases of cross-continent imports likely driven by human migrations. PMID:25161186

Reservoirs override seasonal variability of phytoplankton communities in a regulated Mediterranean river.

PubMed

Tornés, E; Pérez, M C; Durán, C; Sabater, S

2014-03-15

Water hydrology, temperature and transparency, as well as nutrient retention downstream of the reservoirs alter the temporal and spatial distribution patterns of phytoplankton communities in regulated rivers. The seasonal dynamics of phytoplankton communities in the Ebro was analysed in contrasting water flow periods in sections upstream and downstream of three large reservoirs, as well as in an intermediate site. Phytoplankton communities changed in response to seasonal variations in the areas not influenced by the reservoirs, but the phytoplankton distribution downstream of the reservoirs was driven by their particular hydrodynamics. The change in environmental conditions promoted by reservoirs influenced the pattern of replacement between diatoms and green algae of the upstream section. Differences in the phytoplankton community structure, abundance and environmental variables between upstream and downstream sites were maximal during low flow periods. Chlorophytes and dinoflagellates were present during low flow periods upstream of the reservoirs and in the intermediate site. Cocconeis cf. placentula characterized the downstream section, associated to the presence of macrophytes in that section. The present study sheds light on the consequences of river regulation under potential scenarios of climate change, and results could be used to anticipate ecological problems in large regulated rivers under these circumstances. Copyright © 2013 Elsevier B.V. All rights reserved.

Water Safety and Lead Regulation: Physicians' Community Health Responsibilities.

PubMed

Jennings, Bruce; Duncan, Leslie Lyons

2017-10-01

This article reviews the regulation of lead in drinking water, highlighting its epidemiological, engineering, and ethical aspects with a focus on the Flint water crisis. We first discuss water quality policy and its implementation with a focus on lead contamination of water, primarily from pipe systems between a water treatment facility and a tap. We then discuss physicians' roles and ethical responsibilities regarding safe drinking water using a human rights framework. We argue that physicians can play an important role in safeguarding drinking water in their communities by being vigilant, honoring the community's trust in them, and warning, educating, and empowering patients and broader communities so as to protect tap water safety and public health. © 2017 American Medical Association. All Rights Reserved.

Community Environmental Policing: Assessing New Strategies of Public Participation in Environmental Regulation

ERIC Educational Resources Information Center

O'Rourke, Dara; Macey, Gregg P.

2003-01-01

This paper evaluates a new form of public participation in environmental monitoring and regulation advanced through local "bucket brigades," which allow community members to sample air emissions near industrial facilities. These brigades represent a new form of community environmental policing, in which residents participate in collecting,…

Equal Opportunities and Vocational Training. A Survey on Vocational Training Initiatives for Women in the European Community.

ERIC Educational Resources Information Center

Seeland, Suzanne

This report synthesizes findings of a survey of vocational training measures for women in the nine countries of the Western European community. In the first section, some basic figures are presented on numbers of innovative measures, proportion of women gainfully employed, distribution of employed women among economic sectors, and persons…

The ECHI project: health indicators for the European Community.

PubMed

Kramers, Pieter G N

2003-09-01

Within the EU Health Monitoring Programme (HMP), the ECHI project has proposed a comprehensive list of 'European Community Health Indicators'. In the design of the indicator set, a set of explicit criteria was applied. These included: i) be comprehensive and coherent, i.e. cover all domains of the public health field; ii) take account of earlier work, especially that by WHO-Europe, OECD and Eurostat; and iii) cover the priority areas that Member States and Community health policies currently pursue. Flexibility is an important characteristic of the present proposal. In ECHI, this has been emphasized by the definition of 'user-windows'. These are subsets from the overall indicator list, each of which should reflect a specific user's requirement or interest. The proposed indicators are, in most cases, defined as generic indicators, i.e. their actual operational definitions have not yet been attempted. This work has been, and is being carried out to a large part by other projects financed under the HMP, which cover specific areas of public health or areas of data collection. Apart from indicators covered by regularly available data, indicators (or issues) have been proposed for which data are currently difficult to collect but which from a policy point of view would be needed. All this points to the fact that establishing an indicator list which is actually used by Member States is a continuously developing process. This process is now continued by the first strand of the new EU Public Health Action Programme.

[Health policy in the European Union: impact on the Spanish health system].

PubMed

Guimarães, Luisa; Freire, José-Manuel

2007-01-01

This text reviews the impact of European integration on the health sector (public health and health services) by studying European Union (EU) institutions, functioning, and responsibilities through the literature, documents, and authors' observations. The EU does not have direct health responsibilities, but Community legislation has important repercussions on all member states' health policies. This influence affects health protection issues, consumer safety, regulation of medicines and medical devices, mutual recognition of professional qualifications, freedom of movement for health professionals and patients, public contracts and bidding, research, etc. The evolution of EU health policy shows a progressive reinforcement of responsibilities consistent with the objective of reaching a high level of health protection, which in turn affects other European policies. The impact of European integration on the Spanish health system is analyzed as a case study, and key aspects and present and future challenges are highlighted. Lessons are also drawn for regional integration processes to foster equity and efficiency in health.

The exclusion-inclusion spectrum in state and community response to sex offenders in Anglo-American and European jurisdictions.

PubMed

Petrunik, Michael; Deutschmann, Linda

2008-10-01

Continental European and Anglo-American jurisdictions differ with regard to criminal justice and community responses to sex offenders on an exclusion-inclusion spectrum ranging from community protection measures on one end to therapeutic programs in the middle and restorative justice measures on the other end. In the United States, populist pressure has resulted in a community protection approach exemplified by sex offender registration, community notification, and civil commitment of violent sexual predators. Although the United Kingdom and Canada have followed, albeit more cautiously, the American trend to adopt exclusionist community protection measures, these countries have significant community-based restorative justice initiatives, such as Circles of Support and Accountability. Although sex offender crises have recently occurred in continental Europe, a long-standing tradition of the medicalization of deviance, along with the existence of social structural buffers against the influence of victim-driven populist penal movements, has thus far limited the spread of formal community protection responses.

The roles of community biomass and species pools in the regulation of plant diversity

USGS Publications Warehouse

Grace, J.B.

2001-01-01

Considerable debate has developed over the importance of community biomass and species pools in the regulation of community diversity. Attempts to explain patterns of plant diversity as a function of community biomass or productivity have been only partially successful and in general, have explained only a fraction of the observed variation in diversity. At the same time studies that have focused on the importance of species pools have led some to conclude that diversity is primarily regulated in the short term by the size of the species pool rather than by biotic interactions. In this paper, I explore how community biomass and species pools may work in combination to regulate diversity in herbaceous plant communities. To address this problem, I employ a simple model in which the dynamics of species richness are a function of aboveground community biomass and environmentally controlled gradients in species pools. Model results lead to two main predictions about the role of biomass regulation: (1) Seasonal dynamics of richness will tend to follow a regular oscillation, with richness rising to peak values during the early to middle portion of the growing season and then declining during the latter part of the season. (2.) Seasonal dieback of aboveground tissues facilitates the long-term maintenance of high levels of richness in the community. The persistence of aboveground tissues and accumulation of litter are especially important in limiting the number of species through the suppression of recruitment. Model results also lead to two main predictions about the role of species pools: (1) The height and position of peak richness relative to community biomass will be influenced by the rate at which the species pool increases as available soil resources increase. (2) Variations in nonresource environmental factors (e.g. soil pH or soil salinity) have the potential to regulate species pools in a way that is uncorrelated with aboveground biomass. Under extreme conditions

Vocational Guidance and Counselling for Young People and Adults in the European Community. Findings of a Conference (Berlin, West Germany, December 7-8, 1989).

ERIC Educational Resources Information Center

de Vries, Heinz J., Ed.

1990-01-01

This document reports on a conference centered around three topics: vocational guidance in the Member States of the European Community (EC), the "Europeanization" of vocational guidance, and approaches to cross-frontier vocational guidance. Among the recommendations of the conference participants are the following: the tasks of…

Working towards a European Geological Data Infrastructure

NASA Astrophysics Data System (ADS)

van der Krogt, Rob; Hughes, Richard; Pedersen, Mikael; Serrano, Jean-Jacques; Lee, Kathryn A.; Tulstrup, Jørgen; Robida, François

2013-04-01

The increasing importance of geological information for policy, regulation and business needs at European and international level has been recognized by the European Parliament and the European Commission, who have called for the development of a common European geological knowledge base. The societal relevance of geoscience data/information is clear from many current issues such as shale gas exploration (including environmental impacts), the availability of critical mineral resources in a global economy, management and security with regard to geohazards (seismic, droughts, floods, ground stability), quality of (ground-)water and soil and societal responses to the impacts of climate change. The EGDI-Scope project responds to this, aiming to prepare an implementation plan for a pan-European Geological Data Infrastructure (EGDI), under the umbrella of the FP7 e- Infrastructures program. It is envisaged that the EGDI will build on geological datasets and models currently held by the European Geological Surveys at national and regional levels, and will also provide a platform for datasets generated by the large number of relevant past, ongoing and future European projects which have geological components. With European policy makers and decision makers from (international) industry as the main target groups (followed by research communities and the general public) stakeholder involvement is imperative to the successful realization and continuity of the EGDI. With these ambitions in mind, the presentation will focus on the following issues, also based on the first results and experiences of the EGDI-Scope project that started mid-2012: • The organization of stakeholder input and commitment connected to relevant 'use cases' within different thematic domains; a number of stakeholder representatives is currently involved, but the project is open to more extensive participation; • A large number of European projects relevant for data delivery to EGDI has been reviewed

Substantial between-country differences in organising community care for older people in Europe-a review.

PubMed

Van Eenoo, Liza; Declercq, Anja; Onder, Graziano; Finne-Soveri, Harriet; Garms-Homolová, Vjenka; Jónsson, Pálmi V; Dix, Olivia H M; Smit, Johannes H; van Hout, Hein P J; van der Roest, Henriëtte G

2016-04-01

The European population is aging. The main drivers of public spending on health care for people of 65 years and older are hospital admission and admission to long-term care facilities. High quality community care can be a cost-effective and quality solution to respond to the impact of ageing populations on health-care systems. It is unclear how well countries are equipped to provide affordable and quality community care. The aim of this article is to describe and compare community care delivery with care-dependent older people in Europe.  This study is conducted within the European Union-financed IBenC project [Identifying best practices for care-dependent elderly byBenchmarkingCosts and outcomes of community care (FP7)] in which six European countries are involved. To compare the community care delivery with care-dependent older people in these countries, we performed a systematic comparison of macro indicators using metadata complemented with data from multinational surveys.  Data on the following dimensions are described and compared: population of the country, governmental expenditures on health, sources of community health services funding, governmental vision and regulation on community care, community care organisations and care professionals, eligibility criteria for and equity in receiving care and the involvement of informal care.  : Because of the variations in the European community care contexts, the growing demand for community care as a cost-effective and quality solution to the care burden of aging populations will have country-specific impacts. When learning from other countries' best practices, in addition to researchers, policy makers should take full account of local and national care contexts. © The Author 2015. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Access to Higher Education in the European Community: Synthesis Report (Volume 1) and Country Reports (Volume 2).

ERIC Educational Resources Information Center

de Jonge, J. F. M.; And Others

This report examines, country by country, the present state of student access to higher education institutions in the Member States of the European Community (EC), as well as the elements which affect access directly and the elements which can potentially have an effect on access. Volume 1 of the report gives an overview of the methods of data…

Fine Spatial Scale Variation of Soil Microbial Communities under European Beech and Norway Spruce.

PubMed

Nacke, Heiko; Goldmann, Kezia; Schöning, Ingo; Pfeiffer, Birgit; Kaiser, Kristin; Castillo-Villamizar, Genis A; Schrumpf, Marion; Buscot, François; Daniel, Rolf; Wubet, Tesfaye

2016-01-01

The complex interactions between trees and soil microbes in forests as well as their inherent seasonal and spatial variations are poorly understood. In this study, we analyzed the effects of major European tree species ( Fagus sylvatica L. and Picea abies (L.) Karst) on soil bacterial and fungal communities. Mineral soil samples were collected from different depths (0-10, 10-20 cm) and at different horizontal distances from beech or spruce trunks (0.5, 1.5, 2.5, 3.5 m) in early summer and autumn. We assessed the composition of soil bacterial and fungal communities based on 16S rRNA gene and ITS DNA sequences. Community composition of bacteria and fungi was most strongly affected by soil pH and tree species. Different ectomycorrhizal fungi (e.g., Tylospora ) known to establish mutualistic associations with plant roots showed a tree species preference. Moreover, bacterial and fungal community composition showed spatial and seasonal shifts in soil surrounding beech and spruce. The relative abundance of saprotrophic fungi was higher at a depth of 0-10 vs. 10-20 cm depth. This was presumably a result of changes in nutrient availability, as litter input and organic carbon content decreased with soil depth. Overall bacterial community composition showed strong variations under spruce with increasing distance from the tree trunks, which might be attributed in part to higher fine root biomass near spruce trunks. Furthermore, overall bacterial community composition was strongly affected by season under deciduous trees.

Potential application of ecological models in the European environmental risk assessment of chemicals. I. Review of protection goals in EU directives and regulations.

PubMed

Hommen, Udo; Baveco, J M Hans; Galic, Nika; van den Brink, Paul J

2010-07-01

Several European directives and regulations address the environmental risk assessment of chemicals. We used the protection of freshwater ecosystems against plant protection products, biocidal products, human and veterinary pharmaceuticals, and other chemicals and priority substances under the Water Framework Directive as examples to explore the potential of ecological effect models for a refined risk assessment. Our analysis of the directives, regulations, and related guidance documents lead us to distinguish the following 5 areas for the application of ecological models in chemical risk assessment: 1) Extrapolation of organism-level effects to the population level: The protection goals are formulated in general terms, e.g., avoiding "unacceptable effects" or "adverse impact" on the environment or the "viability of exposed species." In contrast, most of the standard ecotoxicological tests provide data only on organism-level endpoints and are thus not directly linked to the protection goals which focus on populations and communities. 2) Extrapolation of effects between different exposure profiles: Especially for plant protection products, exposure profiles can be very variable and impossible to cover in toxicological tests. 3) Extrapolation of recovery processes: As a consequence of the often short-term exposures to plant protection products, the risk assessment is based on the community recovery principle. On the other hand, assessments under the other directives assume a more or less constant exposure and are based on the ecosystem threshold principle. 4) Analysis and prediction of indirect effects: Because effects on 1 or a few taxa might have consequences on other taxa that are not directly affected by the chemical, such indirect effects on communities have to be considered. 5) Prediction of bioaccumulation within food chains: All directives take the possibility of bioaccumulation, and thus secondary poisoning within the food chain, into account. (c) 2010 SETAC.

Air pollution legislation and regulation in the european community: A review essay

NASA Astrophysics Data System (ADS)

O'Riordan, Timothy

Pollution control generally is moving from the specific to the general, from the local to the international, from reactive measures to foresight management, from emission based to technology forced, and from single media managed to integrated. These are trends only, but there is a persistence behind these trends. This suggests that air pollution legislation and regulation will be driven more by international protocols and commitments than by national interests. Since enforcement will remain primarily a national responsibility because individual countries vary in their enthusiasm to meet externally imposed air pollution legislation, the weak link in the regulatory chain may well prove to be practical implementation of legislative intent.

European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States.

PubMed

Qu, Liping; Zou, Wenjun; Wang, YiTao; Wang, Mei

2018-03-15

The European Union (EU) has created a regulatory framework for herbal medicinal products (HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs. A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected. The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States. The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing

The dual oxidase gene BdDuox regulates the intestinal bacterial community homeostasis of Bactrocera dorsalis

PubMed Central

Yao, Zhichao; Wang, Ailin; Li, Yushan; Cai, Zhaohui; Lemaitre, Bruno; Zhang, Hongyu

2016-01-01

The guts of metazoans are in permanent contact with the microbial realm that includes beneficial symbionts, nonsymbionts, food-borne microbes and life-threatening pathogens. However, little is known concerning how host immunity affects gut bacterial community. Here, we analyze the role of a dual oxidase gene (BdDuox) in regulating the intestinal bacterial community homeostasis of the oriental fruit fly Bactrocera dorsalis. The results showed that knockdown of BdDuox led to an increased bacterial load, and to a decrease in the relative abundance of Enterobacteriaceae and Leuconostocaceae bacterial symbionts in the gut. The resulting dysbiosis, in turn, stimulates an immune response by activating BdDuox and promoting reactive oxygen species (ROS) production that regulates the composition and structure of the gut bacterial community to normal status by repressing the overgrowth of minor pathobionts. Our results suggest that BdDuox plays a pivotal role in regulating the homeostasis of the gut bacterial community in B. dorsalis. PMID:26565723

Euroscepticism in Britain and France: Implications for NATO and the European Union

DTIC Science & Technology

2016-03-01

establishment BBC British Broadcasting Corporation CSDP Common Security and Defence Policy ECSC European Coal and Steel Community EDC European Defense...existed since the formation of collective European international organizations such as the European Coal and Steel Community (ECSC) and the European...external coercion or aggression.”142 The EU was formed after a progression of economic and political treaties beginning with the European Coal and

Origin and evolution of European community-acquired methicillin-resistant Staphylococcus aureus.

PubMed

Stegger, Marc; Wirth, Thierry; Andersen, Paal S; Skov, Robert L; De Grassi, Anna; Simões, Patricia Martins; Tristan, Anne; Petersen, Andreas; Aziz, Maliha; Kiil, Kristoffer; Cirković, Ivana; Udo, Edet E; del Campo, Rosa; Vuopio-Varkila, Jaana; Ahmad, Norazah; Tokajian, Sima; Peters, Georg; Schaumburg, Frieder; Olsson-Liljequist, Barbro; Givskov, Michael; Driebe, Elizabeth E; Vigh, Henrik E; Shittu, Adebayo; Ramdani-Bougessa, Nadjia; Rasigade, Jean-Philippe; Price, Lance B; Vandenesch, Francois; Larsen, Anders R; Laurent, Frederic

2014-08-26

Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) was recognized in Europe and worldwide in the late 1990s. Within a decade, several genetically and geographically distinct CA-MRSA lineages carrying the small SCCmec type IV and V genetic elements and the Panton-Valentine leukocidin (PVL) emerged around the world. In Europe, the predominant CA-MRSA strain belongs to clonal complex 80 (CC80) and is resistant to kanamycin/amikacin and fusidic acid. CC80 was first reported in 1993 but was relatively rare until the late 1990s. It has since been identified throughout North Africa, the Middle East, and Europe, with recent sporadic reports in sub-Saharan Africa. While strongly associated with skin and soft tissue infections, it is rarely found among asymptomatic carriers. Methicillin-sensitive S. aureus (MSSA) CC80 strains are extremely rare except in sub-Saharan Africa. In the current study, we applied whole-genome sequencing to a global collection of both MSSA and MRSA CC80 isolates. Phylogenetic analyses strongly suggest that the European epidemic CA-MRSA lineage is derived from a PVL-positive MSSA ancestor from sub-Saharan Africa. Moreover, the tree topology suggests a single acquisition of both the SCCmec element and a plasmid encoding the fusidic acid resistance determinant. Four canonical SNPs distinguish the derived CA-MRSA lineage and include a nonsynonymous mutation in accessory gene regulator C (agrC). These changes were associated with a star-like expansion into Europe, the Middle East, and North Africa in the early 1990s, including multiple cases of cross-continent imports likely driven by human migrations. With increasing levels of CA-MRSA reported from most parts of the Western world, there is a great interest in understanding the origin and factors associated with the emergence of these epidemic lineages. To trace the origin, evolution, and dissemination pattern of the European CA-MRSA clone (CC80), we sequenced a global collection

Fine Spatial Scale Variation of Soil Microbial Communities under European Beech and Norway Spruce

PubMed Central

Nacke, Heiko; Goldmann, Kezia; Schöning, Ingo; Pfeiffer, Birgit; Kaiser, Kristin; Castillo-Villamizar, Genis A.; Schrumpf, Marion; Buscot, François; Daniel, Rolf; Wubet, Tesfaye

2016-01-01

The complex interactions between trees and soil microbes in forests as well as their inherent seasonal and spatial variations are poorly understood. In this study, we analyzed the effects of major European tree species (Fagus sylvatica L. and Picea abies (L.) Karst) on soil bacterial and fungal communities. Mineral soil samples were collected from different depths (0–10, 10–20 cm) and at different horizontal distances from beech or spruce trunks (0.5, 1.5, 2.5, 3.5 m) in early summer and autumn. We assessed the composition of soil bacterial and fungal communities based on 16S rRNA gene and ITS DNA sequences. Community composition of bacteria and fungi was most strongly affected by soil pH and tree species. Different ectomycorrhizal fungi (e.g., Tylospora) known to establish mutualistic associations with plant roots showed a tree species preference. Moreover, bacterial and fungal community composition showed spatial and seasonal shifts in soil surrounding beech and spruce. The relative abundance of saprotrophic fungi was higher at a depth of 0–10 vs. 10–20 cm depth. This was presumably a result of changes in nutrient availability, as litter input and organic carbon content decreased with soil depth. Overall bacterial community composition showed strong variations under spruce with increasing distance from the tree trunks, which might be attributed in part to higher fine root biomass near spruce trunks. Furthermore, overall bacterial community composition was strongly affected by season under deciduous trees. PMID:28066384

Ethical and social issues in presymptomatic testing for Huntington's disease: a European Community collaborative study. European Community Huntington's Disease Collaborative Study Group.

PubMed Central

1993-01-01

An analysis of social and ethical aspects of presymptomatic testing for Huntington's disease has been carried out, based on data on linked DNA markers, from four major testing centres in different European Community countries (Belgium, Italy, Netherlands, and United Kingdom). Information was available on 603 applicants, with 213 final results given, of which 32% gave an increased risk. A series of specific issues and problems were documented systematically for all applicants, results being given on frequency of occurrence and illustrated by individual case histories. The principal issues could be grouped as problems of inappropriate referral, problems involving relatives, and problems relating to disclosure of results. At least one important problem was encountered in 46% of applicants, emphasising the importance of expert counselling, preparation, and support of applicants, and of close liaison between clinical, counselling, and laboratory staff. The extensive and detailed information available for Huntington's disease from this and other studies will be of considerable value in relation to genetic testing for other late onset genetic disorders and will be even more relevant to Huntington's disease now that specific mutation analysis is possible for this disorder. PMID:8133502

Student Mobility in Higher Education in the European Community: Synthesis Report (Volume 1) and Country Reports (Volume 2).

ERIC Educational Resources Information Center

de Jonge, J. F. M.; And Others

The European Community Action Programs for the Mobility of Universities Studies (ERASMUS) provides for the exchange of students who carry out reorganized periods of study from 3 months to 1 year in a member state other than their own. This report examines, country by country, students' ability to move in the higher education sector between member…

Legal frameworks and key concepts regulating diversion and treatment of mentally disordered offenders in European Union member states.

PubMed

Dressing, Harald; Salize, Hans Joachim; Gordon, Harvey

2007-10-01

There is only limited research on the various legal regulations governing assessment, placement and treatment of mentally ill offenders in European Union member states (EU-member states). To provide a structured description and cross-boundary comparison of legal frameworks regulating diversion and treatment of mentally disordered offenders in EU-member states before the extension in May 2004. A special focus is on the concept of criminal responsibility. Information on legislation and practice concerning the assessment, placement and treatment of mentally ill offenders was gathered by means of a detailed, structured questionnaire which was filled in by national experts. The legal regulations relevant for forensic psychiatry in EU-member states are outlined. Definitions of mental disorders given within these acts are introduced and compared with ICD-10 diagnoses. Finally the application of the concept of criminal responsibility by the law and in routine practice is presented. Legal frameworks for the processing and placement of mentally disordered offenders varied markedly across EU-member states. Since May 2004 the European Union has expanded to 25 member states and in January 2007 it will reach 27. With increasing mobility across Europe, the need for increasing trans-national co-operation is becoming apparent in which great variation in legal tradition pertains.

Self-regulated Learning in a Hybrid Science Course at a Community College

NASA Astrophysics Data System (ADS)

Manuelito, Shannon Joy

Community college students are attracted to courses with alternative delivery formats such as hybrid courses because the more flexible delivery associated with such courses provides convenience for busy students. In a hybrid course, face-to-face, structured seat time is exchanged for online components. In such courses, students take more responsibility for their learning because they assume additional responsibility for learning more of the course material on their own. Thus, self-regulated learning (SRL) behaviors have the potential to be useful for students to successfully navigate hybrid courses because the online components require exercise of more personal control over the autonomous learning situations inherent in hybrid courses. Self-regulated learning theory includes three components: metacognition, motivation, and behavioral actions. In the current study, this theoretical framework is used to examine how inducing self-regulated learning activities among students taking a hybrid course influence performance in a community college science course. The intervention for this action research study consisted of a suite of activities that engage students in self-regulated learning behaviors to foster student performance. The specific SRL activities included predicting grades, reflections on coursework and study efforts in course preparation logs, explanation of SRL procedures in response to a vignette, photo ethnography work on their personal use of SRL approaches, and a personalized study plan. A mixed method approach was employed to gather evidence for the study. Results indicate that community college students use a variety of self-regulated learning strategies to support their learning of course material. Further, engaging community college students in learning reflection activities appears to afford some students with opportunities to refine their SRL skills and influence their learning. The discussion focuses on integrating the quantitative and qualitative

Motivation and Self-Regulation in Community College Transfer Students at a Four-Year Online University

ERIC Educational Resources Information Center

List, Alexandra; Nadasen, Denise

2017-01-01

Motivation and self-regulation were examined in a sample of community college transfer students enrolled in a 4-year, online university. The relation between motivation and self-regulation and students' performance was examined, as was the association between these learner characteristics (i.e., motivation and self-regulation) and sociodemographic…

European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

PubMed

Coppens, Patrick; da Silva, Miguel Fernandes; Pettman, Simon

2006-04-03

This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including

Effects of changing climate on European stream invertebrate communities: A long-term data analysis.

PubMed

Jourdan, Jonas; O'Hara, Robert B; Bottarin, Roberta; Huttunen, Kaisa-Leena; Kuemmerlen, Mathias; Monteith, Don; Muotka, Timo; Ozoliņš, Dāvis; Paavola, Riku; Pilotto, Francesca; Springe, Gunta; Skuja, Agnija; Sundermann, Andrea; Tonkin, Jonathan D; Haase, Peter

2018-04-15

Long-term observations on riverine benthic invertebrate communities enable assessments of the potential impacts of global change on stream ecosystems. Besides increasing average temperatures, many studies predict greater temperature extremes and intense precipitation events as a consequence of climate change. In this study we examined long-term observation data (10-32years) of 26 streams and rivers from four ecoregions in the European Long-Term Ecological Research (LTER) network, to investigate invertebrate community responses to changing climatic conditions. We used functional trait and multi-taxonomic analyses and combined examinations of general long-term changes in communities with detailed analyses of the impact of different climatic drivers (i.e., various temperature and precipitation variables) by focusing on the response of communities to climatic conditions of the previous year. Taxa and ecoregions differed substantially in their response to climate change conditions. We did not observe any trend of changes in total taxonomic richness or overall abundance over time or with increasing temperatures, which reflects a compensatory turnover in the composition of communities; sensitive Plecoptera decreased in response to warmer years and Ephemeroptera increased in northern regions. Invasive species increased with an increasing number of extreme days which also caused an apparent upstream community movement. The observed changes in functional feeding group diversity indicate that climate change may be associated with changes in trophic interactions within aquatic food webs. These findings highlight the vulnerability of riverine ecosystems to climate change and emphasize the need to further explore the interactive effects of climate change variables with other local stressors to develop appropriate conservation measures. Copyright © 2017 Elsevier B.V. All rights reserved.

Methane dynamics regulated by microbial community response to permafrost thaw.

PubMed

McCalley, Carmody K; Woodcroft, Ben J; Hodgkins, Suzanne B; Wehr, Richard A; Kim, Eun-Hae; Mondav, Rhiannon; Crill, Patrick M; Chanton, Jeffrey P; Rich, Virginia I; Tyson, Gene W; Saleska, Scott R

2014-10-23

Permafrost contains about 50% of the global soil carbon. It is thought that the thawing of permafrost can lead to a loss of soil carbon in the form of methane and carbon dioxide emissions. The magnitude of the resulting positive climate feedback of such greenhouse gas emissions is still unknown and may to a large extent depend on the poorly understood role of microbial community composition in regulating the metabolic processes that drive such ecosystem-scale greenhouse gas fluxes. Here we show that changes in vegetation and increasing methane emissions with permafrost thaw are associated with a switch from hydrogenotrophic to partly acetoclastic methanogenesis, resulting in a large shift in the δ(13)C signature (10-15‰) of emitted methane. We used a natural landscape gradient of permafrost thaw in northern Sweden as a model to investigate the role of microbial communities in regulating methane cycling, and to test whether a knowledge of community dynamics could improve predictions of carbon emissions under loss of permafrost. Abundance of the methanogen Candidatus 'Methanoflorens stordalenmirensis' is a key predictor of the shifts in methane isotopes, which in turn predicts the proportions of carbon emitted as methane and as carbon dioxide, an important factor for simulating the climate feedback associated with permafrost thaw in global models. By showing that the abundance of key microbial lineages can be used to predict atmospherically relevant patterns in methane isotopes and the proportion of carbon metabolized to methane during permafrost thaw, we establish a basis for scaling changing microbial communities to ecosystem isotope dynamics. Our findings indicate that microbial ecology may be important in ecosystem-scale responses to global change.

Do online pharmacies fit European internal markets?

PubMed

Mäkinen, Mia Maria; Rautava, Päivi Tuire; Forsström, Jari Johannes

2005-05-01

The aim of this article is to consider the suitability of online pharmacies into European internal market area. This required considering the models of present online pharmacies in respect to the existing legislation. Data on online pharmacy settings was collected by looking some online pharmacies, which were found by using Goggle search machine with term "online pharmacy" and by studying websites of some well-known online pharmacies. European legislation and policy were studied from European Union's official website. Online drug markets seem to be increasing in popularity for reasons related to their ready availability and cost benefits. Few online pharmacies are based in Europe, yet online markets are worldwide. Community legislation does not stipulate on the legality of online pharmacies on European internal markets. Instead Community legislation offers framework for electronic commerce that could also include online pharmacy practise. National legislation, however, may rule them out either directly or indirectly. Regardless of European internal markets online pharmacies' cross-border operations are particularly complicated. Preliminary ruling from the European Court of Justice concerning one European online pharmacy's cross-border practise is awaited 2003-2004 and will offer some aspects for future.

77 FR 39731 - Swinomish Indian Tribal Community-Title 15, Chapter 4: Liquor Legalization, Regulation and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Swinomish Indian Tribal Community--Title 15.... ACTION: Notice. SUMMARY: This notice publishes Title 15, Chapter 4: Liquor Legalization, Regulation and... Indian Tribal Community Senate adopted Ordinance No. 296, Enacting Swinomish Tribal Code Title 15...

Governmental policies and measures regulating nitrogen and phosphorus from animal manure in European agriculture.

PubMed

Oenema, O

2004-01-01

This paper discusses governmental policies and measures that regulate the use of animal manure in the European Union (EU-15). Systematic intervention by governments with European agriculture in general started at the end of the 19th century. Major changes in governmental policies on agriculture followed after the establishment of the EU and its Common Agricultural Policy (CAP) in 1957. Environmental side effects of the large-scale intensification of agricultural production were addressed following the reform of the CAP and the implementation of various environmental regulations and directives from the beginning of the 1990s. The Nitrate Directive approved in 1991 has exerted, as yet, the strongest influence on intensive livestock production systems. This directive regulates the use of N in agriculture, especially through its mandatory measures to designate areas vulnerable to nitrate leaching and to establish action programs and codes of good agricultural practice for these areas. These measures have to ensure that for each farm the amount of N applied via livestock manure shall not exceed 170 kg x ha(-1) x yr(-1). These measures have large consequences, especially for countries with intensive animal agriculture, including The Netherlands, Belgium, Denmark, and Ireland. The mean livestock density in these countries is between 1.5 and 4 livestock units/ha, and the average amounts of N in animal manure range from 100 to 300 kg/ha of agricultural land. More than 10 yr after approval of the Nitrate Directive, there appears to be a delay in the implementation and enforcement in many member states, which reflects in part the major complications that arise from this directive for intensive livestock farming. It also reflects the fact that environmental policies in agriculture have economic consequences. The slow progress in the enforcement of environmental legislations in agriculture combined with the increasing public awareness of food safety, animal welfare, and

Comparison of legislation, regulations and national health strategies for palliative care in seven European countries (Results from the Europall Research Group): a descriptive study.

PubMed

Van Beek, Karen; Woitha, Kathrin; Ahmed, Nisar; Menten, Johan; Jaspers, Birgit; Engels, Yvonne; Ahmedzai, Sam H; Vissers, Kris; Hasselaar, Jeroen

2013-07-17

According to EU policy, anyone in need of palliative care should be able to have access to it. It is therefore important to investigate which palliative care topics are subject to legislation and regulations in Europe and how these are implemented in (national) health care plans. This paper aims to deliver a structured overview of the legislation, existing regulations and the different health care policies regarding palliative care in seven European countries. In 2008 an inventory of the organisation of palliative care was developed by the researchers of the Europall project. Included were two open questions about legislation, regulations, and health policy in palliative care. This questionnaire was completed using palliative care experts selected from Belgium, England, France, Germany, the Netherlands, Poland and Spain. Additionally, (grey) literature on palliative care health policy and regulations from the participating countries was collected to complete the inventory. Comparative analysis of country specific information was performed afterwards. In all countries palliative care regulations and policies existed (either in laws, royal decrees, or national policies). An explicit right to palliative care was mentioned in the Belgium, French and German law. In addition, access to palliative care was mentioned by all countries, varying from explicit regulations to policy intentions in national plans. Also, all countries had a national policy on palliative care, although sometimes mainly related to national cancer plans. Differences existed in policy regarding palliative care leave, advance directives, national funding, palliative care training, research, opioids and the role of volunteers. Although all included European countries have policies on palliative care, countries largely differ in the presence of legislation and regulations on palliative care as well as the included topics. European healthcare policy recommendations should support palliative care access

Comparison of legislation, regulations and national health strategies for palliative care in seven European countries (Results from the Europall Research Group): a descriptive study

PubMed Central

2013-01-01

Background According to EU policy, anyone in need of palliative care should be able to have access to it. It is therefore important to investigate which palliative care topics are subject to legislation and regulations in Europe and how these are implemented in (national) health care plans. This paper aims to deliver a structured overview of the legislation, existing regulations and the different health care policies regarding palliative care in seven European countries. Methods In 2008 an inventory of the organisation of palliative care was developed by the researchers of the Europall project. Included were two open questions about legislation, regulations, and health policy in palliative care. This questionnaire was completed using palliative care experts selected from Belgium, England, France, Germany, the Netherlands, Poland and Spain. Additionally, (grey) literature on palliative care health policy and regulations from the participating countries was collected to complete the inventory. Comparative analysis of country specific information was performed afterwards. Results In all countries palliative care regulations and policies existed (either in laws, royal decrees, or national policies). An explicit right to palliative care was mentioned in the Belgium, French and German law. In addition, access to palliative care was mentioned by all countries, varying from explicit regulations to policy intentions in national plans. Also, all countries had a national policy on palliative care, although sometimes mainly related to national cancer plans. Differences existed in policy regarding palliative care leave, advance directives, national funding, palliative care training, research, opioids and the role of volunteers. Conclusions Although all included European countries have policies on palliative care, countries largely differ in the presence of legislation and regulations on palliative care as well as the included topics. European healthcare policy recommendations

Vocational Training in the European Economic Community, with Particular Reference to its Likely Impact on British Training Policy and Practice.

ERIC Educational Resources Information Center

Perry, P. J. C., Comp.

This report documents the visits of a British delegation composed of representatives from three British vocational training organizations to the Commission of the European Economic Community (EEC) and to France, the Federal Republic of Germany, Italy, The Netherlands, and Belgium during June 6-14, 1972. The key areas investigated were: (1) the…

Analysis and Evaluation of Databases on Business and Management Training Schemes for Small and Medium-Sized Enterprises in the European Community.

ERIC Educational Resources Information Center

Allesch, Jurgen; Preiss-Allesch, Dagmar

This report describes a study that identified major databases in operation in the 12 European Community countries that provide small- and medium-sized enterprises with information on opportunities for obtaining training and continuing education. Thirty-five databases were identified through information obtained from telephone interviews or…

Protecting Animals and Enabling Research in the European Union: An Overview of Development and Implementation of Directive 2010/63/EU.

PubMed

Olsson, I Anna S; Silva, Sandra Pinto da; Townend, David; Sandøe, Peter

2016-05-01

In 1986, European Directive 86/609/EEC, regulating the use of animals in research, was one of the first examples of common legislation to set standards for animal protection across the Member States of the former European Economic Community, now the European Union, with the aim of securing a level European playing field. Starting in 2002, a process of revising European animal experimentation legislation was undertaken, with one of its key aims being to ensure high standards of welfare for laboratory animals across Europe. This resulted in Directive 2010/63/EU, which has regulated this activity in Europe since 2013. Since this is a European Union Directive, transposition into national legislation is a necessary and important part of the implementation of the new legislation. This paper gives an overview of the transposition process followed by an analysis of the potential to reach the different objectives of the directive, particularly with a focus on securing the same high standards of animal protection across member countries. The analysis focuses on three separate issues: (1) minimum standards for laboratory animal housing and care, (2) restrictions on the use of certain animal species, and (3) project review and authorization. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Is "Better Regulation" Possible? Formal and Substantive Quality in the Impact Assessments in Education and Culture of the European Commission

ERIC Educational Resources Information Center

Souto-Otero, Manuel

2013-01-01

This article explores the initial results produced by the European Commission's "better regulation agenda", which aims to stimulate productivity and employment, on the use of evidence and its potential to enhance democratic governance. The article finds that implausible rational models of policy making dictate the ways in which the…

The Development of the European Information Market through Education and Training--The Portuguese Experience.

ERIC Educational Resources Information Center

Correia, Ana Maria Ramalho; Wilson, Tom

1993-01-01

Describes Portugal's role in the development of a European information market. Highlights include the role of the European Economic Community, particularly the Commission of the European Communities; information management education at the University of Sheffield in Portugal; and future possibilities. (eight references) (LRW)

Effect of African- and European-American maternal attitudes and limit-setting strategies on children's self-regulation.

PubMed

LeCuyer, Elizabeth A; Swanson, Dena P; Cole, Robert; Kitzman, Harriet

2011-12-01

The effect of maternal attitudes and limit-setting strategies on children's self-regulation (measured as committed compliance) was compared in 151 African-American (AA) and 108 European-American (EA) mothers and their 3-year-old children. There were no ethnic differences in children's compliance, however ethnicity moderated the relationship between maternal authoritarian attitudes and children's compliance. Higher authoritarian attitudes predicted less children's compliance in the EA sample, but greater compliance in the AA sample. Observational limit-setting data revealed that in both ethnic groups, maternal authoritarian attitudes influenced children's self-regulation through maternal use of lower-power (gentle) verbal strategies, fewer physical strategies, and judicious use of higher-power verbal strategies. The findings indicate that the meaning and purpose of authoritarian attitudes varies across these mothers' socio-cultural contexts. Copyright © 2011 Wiley Periodicals, Inc.

The Impact of State Authorization Regulations on a Statewide Community College System

ERIC Educational Resources Information Center

Albo-Lopez, Nicole M.

2016-01-01

This concurrent mixed methods study revealed the impacts of the Title IV, Federal Regulation, State Authorization (SA), on a statewide community college system, with regard to staffing, establishment of local processes, obtainment of authorizations, fiscal resources, and student enrollment. The study takes place within the California community…

The impact of the European Working Time Regulations on Ophthalmic Specialist Training--a national trainee survey.

PubMed

O'Gallagher, M K; Lewis, G; Mercieca, K; Moutray, T

2013-01-01

To assess ophthalmic trainees' perspective of the impact of the European Working Time Regulations (EWTR) on their training. All trainees in ophthalmology in the UK were emailed a link to an electronic survey asking about their experiences of the EWTR. 324 trainees (46% of those invited) responded to the survey. 44.4% of trainees reported that their posts were compliant with the EWTR. 40.7% felt that training had been adversely affected. 49.1% thought that ophthalmic trainees should opt out of the EWTR to work more than 48 h per week, with 57 the mean number of hours suggested appropriate. Many ophthalmic trainees in the United Kingdom are working in rotas which are not compliant with the European Working Time Directive. Many trainees feel that implementation of the EWTD has had a negative effect on training and feel it would be acceptable to work a higher number of hours per week. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

The European Union's REACH regulation: a review of its history and requirements.

PubMed

Williams, E Spencer; Panko, Julie; Paustenbach, Dennis J

2009-01-01

In 2006, the European Union (EU) promulgated a monumental regulatory initiative for the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). To date, several thousand pages of text have been needed to describe the expectations of this regulation. There were numerous reasons for the promulgation of REACH, but, by and large, it is an extension of the global desire to produce fewer industrial chemicals, to understand the possible human and ecological hazards of those that are produced, and to insure that any major threat is anticipated, as well as prevented. Most industry-related groups consider it the most wide-ranging and costly regulatory initiatives related to health risk assessment ever to be promulgated. This review presents a description of REACH that should inform scientists, managers, and others about its objectives and the means to satisfy them. Registration is required for all chemicals manufactured or imported into the EU, unless specifically exempted. Registration is expected to be a collaborative process among companies, which will generate a dossier containing data on physicochemical characteristics, as well as toxicological and ecotoxicological properties. Though the magnitude of the gaps in the data required for registration is uncertain at this point, it is clear that basic toxicology testing will have to be conducted for many chemical substances that have not undergone formal review up to this point. For many chemicals, an examination of hazards and risks arising from the use of these substances will also be required in the form of a chemical safety report (CSR). Beginning with the dual processes of dossier and substance evaluation, the European Chemicals Agency (ECHA), the Member States of the EU, and the European Commission will identify chemicals that may pose unacceptable hazards to human health and/or the environment, and will curtail or restrict their usage. The implementation of REACH will expand and deepen the

A review of the organization, regulation, and financing practices of postgraduate education in clinical nursing in 12 European countries.

PubMed

Rautiainen, Elina; Vallimies-Patomäki, Marjukka

2016-01-01

The aim of this study was to generate information of postgraduate education in clinical nursing in the EU member states. Data were collected via a structured electronic questionnaire and the questionnaire was sent to the government chief nurses in 26 EU countries in May 2013. Response rate was 46% (n=12). In total, 42 domains of specialization were identified. The most common domains were intensive care, mental health, operating room, emergency care, and pediatrics. Specialization programs were organized by university in two of the respondent countries, as residency program in one country, and as a mix of them in four countries. Regulation practices varied remarkably between the countries: scope of practice, subjects, entry requirements, length of education, description of the minimum competence requirements, and education standards related to the specialization programs were most often regulated by act, decree or other regulation. In some of the countries, no registration was required beyond the initial registration, whereas in some others, registration practices varied depending on the specialization program. New information was gathered on the regulation practices of postgraduate education in clinical nursing in the European Region concerning title provision, entry requirements, and financing practices. The awarded title on specialization programs depended on the level of postgraduate education, and the title might vary between the domains. General clinical experience was included in the entry requirements in seven countries. The government was mainly responsible for financing the postgraduate education in four countries, employer in three countries, and in the rest of the countries, there was a combination of different financiers. The importance of knowledge exchange on postgraduate education across the European countries needs to be acknowledged. Information provided by this study on international regulation practices provides useful information for the policy

The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012.

PubMed

Peschel, Wieland

2014-12-02

The provisions for the simplified registration of traditional herbal medicinal products in the European Union were introduced by Directive 2004/24/EC amending Directive 2001/83/EC (Chapter 2a) in 2004. Since implementation in the European member states until December 2012 a total of 1015 registrations (traditional use) and 514 authorisations (well-established use) have been granted for products containing substances/ preparations from about 200 different herbal drugs. The overall number of received applications with more than one third still under assessment suggests a further increase for the next years. This review summarises the main features of registered and authorised herbal medicinal products in the EU and evaluates available data against provisions of Directive 2004/24/EC and European standards established by the Committee on Herbal Medicinal Products at the European Medicines Agency. The supportive function of Community herbal monographs is described as regards availability and their use in national procedures, which is complemented by an analysis of specific future challenges from experiences made with the implementation of Directive 2004/24/EC so far. Copyright © 2014. Published by Elsevier Ireland Ltd.

Herbs and dietary supplements in the European Union: a review of the regulations with special focus on Germany and Poland.

PubMed

Konik, Ewa A; Jungling, Roman C; Bauer, Brent A

2011-03-01

In the European Union, the manufacturing of and the trade in herbs and dietary supplements are regulated by pharmaceutical and food laws. While dietary supplements are subject to food laws, provisions dealing with herbs are primarily to be found in pharmaceutical regulations. Having a basic understanding of the complexities of this regulatory environment can help clinicians and their patients understand the unique challenges and opportunities presented by EU herbs and supplements and may help inform regulatory practices in other countries struggling to ensure quality and safety of such products.

The European Innovation Partnership on Active and Healthy Ageing Synergies: Protocol for a Prospective Observational Study to Measure the Impact of a Community-Based Program on Prevention and Mitigation of Frailty (ICP - PMF) in Community-Dwelling Older Adults.

PubMed

Liotta, G; Orfila, F; Vollenbroek-Hutten, M; Roller-Winsberger, R; Illario, M; Musian, D; Alvino, S; O'Caoimh, R; Cano, A; Molloy, W; Iaccarino, G; Marazzi, M C; Inzerilli, M C; Madaro, O; Paul, C; Csonka, P; Vince, A C; Menditto, E; Maggio, M; Scarcella, P; Gilardi, F; Lucaroni, F; Abete, P; Girardi, V; Barra, R; Palombi, L

2016-11-01

Aim of this paper is to describe the protocol of the study "Impact of a Community-based Program on Prevention and Mitigation of Frailty in community-dwelling older adults" developed in the framework of the European Innovation Partnership on Active and Healthy Ageing. This proposal has been developed by the Partnership Action groups on frailty, fall prevention and polypharmacy in older. The proposal wants to assess the impact of community-based programs aimed to counteract three main outcomes related to frailty: hospitalization, institutionalization and death. Bringing together researchers from seven European countries, the proposal aims to achieve the critical mass and the geographical extension enough to provide information useful to all older European citizens. An observational study will be carried out to calculate the incidence of the different outcomes in relation to the various interventions that will be assessed; results will be compared with data coming from already established national, regional and local dataset using the observed/expected approach. The sample will be made up by at least 2000 citizens for each outcome. All the citizens will be assessed at the baseline with two multidimensional questionnaires: the RISC questionnaire and the Short Functional Geriatric Evaluation questionnaire. The outcomes will be assessed every six-twelve months.

The future of tobacco product regulation and labelling in Europe: implications for the forthcoming European Union directive.

PubMed

Bates, C; McNeill, A; Jarvis, M; Gray, N

1999-01-01

The European Commission has announced that it is considering legislation concerning further restrictions on cigarette tar and nicotine yields, as well as new provisions to regulate additives and the labelling of tobacco products. This report considers these issues and their relation to public health. In particular, we argue that further reductions in tar and nicotine yields as measured by the International Standards Organisation/Federal Trade Commission (ISO/FTC) method will be largely cosmetic and certainly misleading to consumers. If a new directive uses the ISO/FTC methodology as a basis for regulation, it risks lending further official support to the concept of "low tar" cigarettes, which may be used by smokers as an alternative to smoking cessation. Although new regulations based on the ISO/FTC methodology may appear to offer health gains, these will be illusory and there may even be negative health consequences, as has been the case with these tests up to the present. We therefore make the following recommendations for the way forward.

Equality of Opportunity and Vocational Training Five Years on...Vocational Training Measures for Women in the European Community. Synthesis Report and Recommendations.

ERIC Educational Resources Information Center

Oels, Monika; Seeland, Suzanne

This document includes four chapters, a bibliography, notes, and two appendices. Chapter 1 briefly indicates the purpose of the report, to look retrospectively at innovative vocational training programs initiated for women in the European Community (EC). Chapter 2 describes general developments since 1978, including the legal background, the…

Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.

PubMed

Mulinari, Shai; Davis, Courtney

2017-11-09

Relenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs. We conducted a qualitative analysis of United States and European Union regulatory appraisals for Relenza to investigate the reasons for divergent regulatory interpretations, pertaining to Relenza's capacity to alleviate symptoms and reduce frequency of complications of influenza. In Europe, Relenza was evaluated via the so-called national procedure with Sweden as the reference country. We show that FDA reviewers, unlike their European (i.e. Swedish) counterpart, (1) rejected the manufacturer's insistence on pooling efficacy data, (2) remained wary of subgroup analyses, and (3) insisted on stringent statistical analyses. These differences meant that the FDA was less likely to depart from prevailing regulatory and scientific standards in interpreting trial results. We argue that the differences are explained largely by divergent institutionalised review methodologies, i.e. the European regulator's reliance on manufacturer-compiled summaries compared to the FDA's examination of original data and documentation from trials. The FDA's more probing and meticulous evaluative methodology allowed its reviewers to develop 'deep' knowledge concerning the clinical and statistical facets of trials, and more informed opinions regarding suitable methods for analysing trial results. These findings challenge the current emphasis on evaluating regulatory performance mainly in terms of speed of review. We propose that persistent uncertainty and knowledge deficits regarding NIs could have been ameliorated had regulators engaged in the public debates over the drugs' efficacy and

Next generation capacity building for the GEOSS community - an European approach

NASA Astrophysics Data System (ADS)

Bye, B. L.

2016-12-01

The Group on Earth observation embarked on the next 10 year phase with an ambition to streamline and futher develop its achievements in building the Global Earth Observing System of Systems (GEOSS). The NextGEOSS project evolves the European vision of GEOSS data exploitation for innovation and business, relying on the three main pillars of engaging communities, delivering technological developments and advocating the use of GEOSS, in order to support the creation and deployment of Earth observation based innovative research activities and commercial services. In this presentation we will present the new integrated approach to capacity building engaging the various actors involved in the entire value-chain from data providers to decision-makers. A presentation of the general approach together with concrete pilot cases will be included.In this work it will be shown how we integrate new technological development and societial change enabling GEO and GEOSS to adapt to the current environment. The result is important for better decision-making and better use of our limited resources to manage our planet.

Corporate coalitions and policy making in the European Union: how and why British American Tobacco promoted "Better Regulation".

PubMed

Smith, Katherine Elizabeth; Fooks, Gary; Gilmore, Anna B; Collin, Jeff; Weishaar, Heide

2015-04-01

Over the past fifteen years, an interconnected set of regulatory reforms, known as Better Regulation, has been adopted across Europe, marking a significant shift in the way that European Union policies are developed. There has been little exploration of the origins of these reforms, which include mandatory ex ante impact assessment. Drawing on documentary and interview data, this article discusses how and why large corporations, notably British American Tobacco (BAT), worked to influence and promote these reforms. Our analysis highlights (1) how policy entrepreneurs with sufficient resources (such as large corporations) can shape the membership and direction of advocacy coalitions; (2) the extent to which "think tanks" may be prepared to lobby on behalf of commercial clients; and (3) why regulated industries (including tobacco) may favor the use of "evidence tools," such as impact assessments, in policy making. We argue that a key aspect of BAT's ability to shape regulatory reform involved the deliberate construction of a vaguely defined idea that could be strategically adapted to appeal to diverse constituencies. We discuss the theoretical implications of this finding for the Advocacy Coalition Framework, as well as the practical implications of the findings for efforts to promote transparency and public health in the European Union. Copyright © 2015 by Duke University Press.

Abandoned floodplain plant communities along a regulated dryland river

USGS Publications Warehouse

Reynolds, L. V.; Shafroth, Patrick B.; House, P. K.

2014-01-01

Rivers and their floodplains worldwide have changed dramatically over the last century because of regulation by dams, flow diversions and channel stabilization. Floodplains no longer inundated by river flows following dam-induced flood reduction comprise large areas of bottomland habitat, but the effects of abandonment on plant communities are not well understood. Using a hydraulic flow model, geomorphic mapping and field surveys, we addressed the following questions along the Bill Williams River, Arizona: (i) What per cent of the bottomland do abandoned floodplains comprise? and (ii) Are abandoned floodplains quantitatively different from adjacent xeric and riparian surfaces in terms of vegetation composition and surface sediment? We found that nearly 70% of active channel and floodplain area was abandoned following dam installation. Abandoned floodplains along the Bill Williams River tend to be similar to each other yet distinct from neighbouring habitats: they have been altered physically from their historic state, leading to distinct combinations of surface sediments, hydrology and plant communities. Abandoned floodplains may transition to xeric communities over time but are likely to retain some riparian qualities as long as there is access to relatively shallow ground water. With expected increases in water demand and drying climatic conditions in many regions, these surfaces and associated vegetation will continue to be extensive in riparian landscapes worldwide

Case-control studies in cancer patients as a surveillance system of occupational exposure in the European Community. European Community Working Party.

PubMed Central

Rona, R J; Taub, N A; Rasmussen, S

1993-01-01

STUDY OBJECTIVE--The main aim was to detect known relationships between lung and blood cancers and various occupational exposures (using job titles as proxies) using a case-control design. The suitability of this system for routine surveillance could then be assessed. DESIGN--A case-control study was carried out in 1989. SETTING--Hospitals in eight European Community countries. SUBJECTS--Men aged 25 to 75 years with incident and prevalent cancer of the lung (190 cases), haematopoietic system (210 cases), or gastrointestinal tract (245 controls) were studied. MEASUREMENTS AND MAIN RESULTS--The crude estimate of the overall odds ratio exposure (OR) for relevant occupational exposure of lung cancer relative to gastrointestinal cancer was 1.20 (95% confidence interval (CI) 0.82, 1.77). In a logistic regression analysis adjusting for country, age at diagnosis, smoking, and alcohol consumption, the overall OR was not greatly changed. A significant interaction of occupational exposure and age at diagnosis showed that lung cancer patients diagnosed at a younger age had a higher OR than patients diagnosed at an older age. Thus, the overall, insignificant result may have been due to a low reliability of occupational history in older age or to a selective mechanism related to age. The overall OR for occupational exposure of cancer of the blood relative to gastrointestinal cancer was 0.88 (95% CI 0.60, 1.31). The logistic regression analysis did not alter these results. CONCLUSION--A surveillance based on a case-control design using job titles would not be sensitive enough to detect possible occupational risks. PMID:8228771

European Research on life in extreme environments, setting up research priorities and coordinating the community: the CAREX project

NASA Astrophysics Data System (ADS)

Rettberg, P.; Ellis-Evans, C.; Prieur, D.; Loreto, F.; Walter, N.; Le Bris, N.; Elster, J.; Amils, R.; Marteinsson, V.

2008-09-01

Life in Extreme Environments is an emerging area of research in which Europe has considerable expertise but a relatively fragmented research infrastructure. The science of such environments has enormous relevance for our knowledge of the diversity and environmental limits of microbial, plant and animal life and the novel strategies employed for survival and growth. Such studies are essential in understanding how life established on the early Earth and in assessing the possibilities for life on other planetary bodies. These environments are also a rich source of novel exploitable compounds. At the European level, there is a need for better coordination of life in extreme environments research, the FP7-funded CAREX project aims to address this need by developing a clearly identifiable, dynamic and durable community. Establishing this community will encourage greater interdisciplinarity and increasing knowledge of extreme environments. It will provide a target for young career scientists and allow a more focussed dialogue with other science areas, with funding agencies, with industrial groups and with international organisations outside Europe. CAREX will last for three years and with a wide scope covering microbial life, plant adaptation and animal adaptation to various marine, polar, terrestrial extreme environments as well as outer space. CAREX's outputs will include a strategic roadmap for European life in extreme environments research (including enabling technologies), diverse opportunities for knowledge transfer, standardisation of methodologies, encouragement and support for early career scientists and a network of links to relevant organisations. These deliverables together with improved community networking, supported by newsletters, promotional leaflets, a series of science publications and an interactive web portal, will help consolidate the community and its identity. Outcomes will be facilitated through science/technology workshops, diverse forums, field

Multiple Hub Network Choice in the Liberalized European Market

NASA Technical Reports Server (NTRS)

Berechman, Joseph; deWit, Jaap

1997-01-01

A key question that so far has received relatively little attention in the germane literature is that of the changes at various airports as a result of the EU liberalization policies. That is, presently, most major European airports still benefit from the so-called home-carrier phenomenon where the country's publicly or semi-publicly owned carrier uses the country's main airport as its gateway hub and, consequently, the home-carrier is also the principal user of this airport (in terms of proportion of total aircraft movements, number of passengers transported, connections, slots ownership, etc.). The country's main airport has substantially benefited from these monopoly conditions of airline captivity, strongly determined by the bilateral system of international air transport regulation. Therefore, European major airports were used to operate in essentially different markets, compared to the increasingly competitive markets of their home based carriers. This partly explains relative stability of transport volumes and financial results of European major airports compared to the relatively volatile financial results of most European national airlines. However, the liberalization of European aviation is likely to change this situation. Market access is open now to all community carriers, i.e. carriers with majority ownership and effective control in the hands of EU citizens. Ticket prices are free, governments can only intervene in case of dumping or excessive pricing. A community airline can choose its seat in any of the 15 member states. Licensing procedures are harmonized between member states. In the last few months community carriers have had unrestricted route access within the EU. Most probably this development will be extended to countries inside and outside Europe. Last year the European Commission got the mandate to start negotiations with 10 other European countries. In the meantime the EC has also started negotiations with the USA on so-called soft rights

Impacts of family and community violence exposure on child coping and mental health.

PubMed

Mohammad, Esror Tamim; Shapiro, Ester R; Wainwright, Laurel D; Carter, Alice S

2015-02-01

An ecological stress process model was employed to explore relations between children's exposures to family and community violence and child mental health, and emotionally-regulated coping (ERC) as a protective factor among Latino, European-American, and African-American school-aged children (n = 91; girls, n = 50[54 %]) living in single-parent families who were either homeless and residing in emergency shelters or housed but living in poverty. Mothers reported domestic violence experiences and their child's history of physical/sexual abuse, community violence exposures, and mental health. Children reported on exposure to community violence, internalizing symptoms, and coping. The mental health impacts of multi-level violence exposures and ERC as a moderator of associations between violence exposures and child mental health was tested with structural equation modeling. Family abuse was uniquely associated with PTSD, and community violence with anxiety and aggression. Latent interaction tests revealed that ERC moderated relations between family abuse and anxiety, aggression and PTSD. Emotionally-regulated coping appears to play a protective role for children's mental health in contexts of violence exposure, offering opportunities for intervention and prevention.

The European General Data Protection Regulation: challenges and considerations for iPSC researchers and biobanks

PubMed Central

Morrison, Michael; Bell, Jessica; George, Carol; Harmon, Shawn; Munsie, Megan; Kaye, Jane

2017-01-01

Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general. PMID:28976812

The Social Dialogue in the Member States of the European Community in the Field of Vocational Training and Continuing Training--Synthesis Report.

ERIC Educational Resources Information Center

Sellin, B.; And Others

This document describes the current links between the world of work (employees, employers, industrial sectors, and companies) and the world of vocational training (in-company, inter-company, and school-based training bodies) in member states of the European Community; and the degree and nature of the involvement of the social partners in the…

Crosstalk Regulates the Capacity for Robust Collective Decision Making in Heterogeneous Microbial Communities

NASA Astrophysics Data System (ADS)

Yusufaly, Tahir; Boedicker, James

Microbial communities frequently communicate via quorum sensing (QS), where cells produce, secrete, and respond to a threshold level of an autoinducer (AI) molecule, thereby modulating density-dependent gene expression. However, the biology of QS remains incompletely understood in heterogeneous communities, where crosstalk between distinct QS systems leads to novel effects. Such knowledge is necessary both for understanding signaling in real microbial communities, and for the rational design of synthetic communities with designer properties. As a step towards this goal, we investigate the effects of crosstalk between Gram-negative bacteria communicating via LuxI/LuxR-type QS systems, with acyl-homoserine lactone (AHL) AI molecules. After mapping QS in a heterogeneous community onto an artificial neural network model, we systematically analyze how heterogeneity regulates the community's capability for stable yet flexible decision making. We find that there are preferred distributions of interactions which provide optimal tradeoffs between capacity, or the number of different decisions a population can make, and robustness, or the tolerance of the community to disturbances. We compare our results to inferences made from experimental data, and critically discuss implications for the biological significance of crosstalk.

An overview on European SPS activities

NASA Technical Reports Server (NTRS)

Reinhartz, K. K.

1980-01-01

The organization of space and energy research in Europe is discussed. The European situation is highlighted with emphasis on the dependency of energy imports and on the energy requirements of Europe. The status of SPS research in the countries that form the European Space Agency was reviewed. It is concluded that in view of the unfavorable geographical and climatic situation of large parts of Europe, terrestrial solar energy conversion is unlikely to make a significant contribution to Europe's future energy supply. Thus, SPS development is of special interest to the European community.

Has the impact of the working time regulations changed neurosurgical trainees' attitudes towards the European working time directive 5 years on?

PubMed

Cowie, Christopher J A; Pešić-Smith, Jonathan D; Boukas, Alexandros; Nelson, Richard J

2013-10-01

We report the results from a survey of the British Neurosurgical Trainees' Association which aimed to assess current rota patterns and their compliance with the government's working time regulations. The survey questioned whether trainees felt that shift working, imposed as a result of the European working time directive, is continuing to impact on patient care and training opportunities in neurosurgery. The responses to this survey indicate that neurosurgical trainees remain concerned with the impact that the current working time regulations have on all facets of their work: training, work- life balance, and the provision of patient care. The survey comments show that the majority would support a change in legislation to allow greater flexibility in the working time regulations.

A European Perspective on the Promotion of Women's Career Aspirations.

ERIC Educational Resources Information Center

Lasonen, Lahja Johanna

Although commitment to equal opportunities in employment has been a major component of European Community legislation and although increasing numbers of European women are entering professions, women throughout Europe still face many barriers to advancing in their professions. Since the early 1970s, European governments including Finland have…

Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the area of blood glucose and insulin concentrations.

PubMed

Martini, Daniela; Biasini, Beatrice; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

2018-04-01

Most requests for authorization to bear health claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate health claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of health claims.

Predicting wetland plant community responses to proposed water-level-regulation plans for Lake Ontario: GIS-based modeling

USGS Publications Warehouse

Wilcox, D.A.; Xie, Y.

2007-01-01

Integrated, GIS-based, wetland predictive models were constructed to assist in predicting the responses of wetland plant communities to proposed new water-level regulation plans for Lake Ontario. The modeling exercise consisted of four major components: 1) building individual site wetland geometric models; 2) constructing generalized wetland geometric models representing specific types of wetlands (rectangle model for drowned river mouth wetlands, half ring model for open embayment wetlands, half ellipse model for protected embayment wetlands, and ellipse model for barrier beach wetlands); 3) assigning wetland plant profiles to the generalized wetland geometric models that identify associations between past flooding / dewatering events and the regulated water-level changes of a proposed water-level-regulation plan; and 4) predicting relevant proportions of wetland plant communities and the time durations during which they would be affected under proposed regulation plans. Based on this conceptual foundation, the predictive models were constructed using bathymetric and topographic wetland models and technical procedures operating on the platform of ArcGIS. An example of the model processes and outputs for the drowned river mouth wetland model using a test regulation plan illustrates the four components and, when compared against other test regulation plans, provided results that met ecological expectations. The model results were also compared to independent data collected by photointerpretation. Although data collections were not directly comparable, the predicted extent of meadow marsh in years in which photographs were taken was significantly correlated with extent of mapped meadow marsh in all but barrier beach wetlands. The predictive model for wetland plant communities provided valuable input into International Joint Commission deliberations on new regulation plans and was also incorporated into faunal predictive models used for that purpose.

Advancing the 3Rs in Regulatory Toxicology - Carcinogenicity Testing: Scope for Harmonisation and Advancing the 3Rs in Regulated Sectors of the European Union

EPA Science Inventory

Abstract Different government agencies operating in the European Union regulate different types of chemical products, but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where ...

Sexual violence and sub-Saharan migrants in Morocco: a community-based participatory assessment using respondent driven sampling.

PubMed

Keygnaert, Ines; Dialmy, Abdessamad; Manço, Altay; Keygnaert, Jeroen; Vettenburg, Nicole; Roelens, Kristien; Temmerman, Marleen

2014-05-08

The European Union contracted Morocco to regulate migration from so-called “transit migrants” from Morocco to Europe via the European Neighbourhood Policy. Yet, international organisations signal that human, asylum and refugee rights are not upheld in Morocco and that many sub-Saharan migrants suffer from ill-health and violence. Hence, our study aimed at 1) investigating the nature of violence that sub-Saharan migrants experience around and in Morocco, 2) assessing which determinants they perceive as decisive and 3) formulating prevention recommendations. Applying Community-Based Participatory Research, we trained twelve sub-Saharan migrants as Community Researchers to conduct in-depth interviews with peers, using Respondent Driven Sampling. We used Nvivo 8 to analyse the data. We interpreted results with Community Researchers and the Community Advisory Board and commonly formulated prevention recommendations. Among the 154 (60 F-94 M) sub-Saharan migrants interviewed, 90% reported cases of multiple victimizations, 45% of which was sexual, predominantly gang rape. Seventy-nine respondents were personally victimized, 41 were forced to witness how relatives or co-migrants were victimized and 18 others knew of peer victimisation. Severe long lasting ill-health consequences were reported while sub-Saharan victims are not granted access to the official health care system. Perpetrators were mostly Moroccan or Algerian officials and sub-Saharan gang leaders who function as unofficial yet rigorous migration professionals at migration ‘hubs’. They seem to proceed in impunity. Respondents link risk factors mainly to their undocumented and unprotected status and suggest that migrant communities set-up awareness raising campaigns on risks while legal and policy changes enforcing human rights, legal protection and human treatment of migrants along with severe punishment of perpetrators are politically lobbied for. Sub-Saharan migrants are at high risk of sexual

Sexual violence and sub-Saharan migrants in Morocco: a community-based participatory assessment using respondent driven sampling

PubMed Central

2014-01-01

Background The European Union contracted Morocco to regulate migration from so-called “transit migrants” from Morocco to Europe via the European Neighbourhood Policy. Yet, international organisations signal that human, asylum and refugee rights are not upheld in Morocco and that many sub-Saharan migrants suffer from ill-health and violence. Hence, our study aimed at 1) investigating the nature of violence that sub-Saharan migrants experience around and in Morocco, 2) assessing which determinants they perceive as decisive and 3) formulating prevention recommendations. Methods Applying Community-Based Participatory Research, we trained twelve sub-Saharan migrants as Community Researchers to conduct in-depth interviews with peers, using Respondent Driven Sampling. We used Nvivo 8 to analyse the data. We interpreted results with Community Researchers and the Community Advisory Board and commonly formulated prevention recommendations. Results Among the 154 (60 F-94 M) sub-Saharan migrants interviewed, 90% reported cases of multiple victimizations, 45% of which was sexual, predominantly gang rape. Seventy-nine respondents were personally victimized, 41 were forced to witness how relatives or co-migrants were victimized and 18 others knew of peer victimisation. Severe long lasting ill-health consequences were reported while sub-Saharan victims are not granted access to the official health care system. Perpetrators were mostly Moroccan or Algerian officials and sub-Saharan gang leaders who function as unofficial yet rigorous migration professionals at migration ‘hubs’. They seem to proceed in impunity. Respondents link risk factors mainly to their undocumented and unprotected status and suggest that migrant communities set-up awareness raising campaigns on risks while legal and policy changes enforcing human rights, legal protection and human treatment of migrants along with severe punishment of perpetrators are politically lobbied for. Conclusion Sub

Evaluation of Design Assurance Regulations for Safety of Space Navigation Services

NASA Astrophysics Data System (ADS)

Ratti, B.; Sarno, M.; De Andreis, C.

2005-12-01

The European Space Agency (ESA), the European Community (EC), and the European Organisation for the Safety of Air Navigation (Eurocontrol) are contributing to the development of a Global positioning and Navigation Satellite System, known as GNSS. The development programme is carried out in two main steps:• GNSS-1: the first-generation system, based on signals received from the GPS (USA) and GLONASS (Russia) constellations, and augmentation systems like EGNOS (European Geostationary Navigation Overlay Service)• GNSS-2: the second-generation system, that will achieve the ultimate objective of European sovereignty for position determination, navigation and time dissemination. This system, named Galileo, comprises a global space and ground control infrastructure.The Galileo navigation signal will be used in the frame of safety-critical transport applications, thus it is necessary to assess the space safety assurance activity against the civil safety regulations and safety management system.. RTCA DO-254 and IEC 61508 standards, considered as part of best practice engineering references, for the development of safety- related systems in most applications, were selected during phases B2 and C0 of the Galileo project for this purpose.

[Genetically modified plants and food safety. State of the art and discussion in the European Union].

PubMed

Schauzu, M

2004-09-01

Placing genetically modified (GM) plants and derived products on the European Union's (EU) market has been regulated by a Community Directive since 1990. This directive was complemented by a regulation specific for genetically modified and other novel foods in 1997. Specific labelling requirements have been applicable for GM foods since 1998. The law requires a pre-market safety assessment for which criteria have been elaborated and continuously adapted in accordance with the state of the art by national and international bodies and organisations. Consequently, only genetically modified products that have been demonstrated to be as safe as their conventional counterparts can be commercialized. However, the poor acceptance of genetically modified foods has led to a de facto moratorium since 1998. It is based on the lack of a qualified majority of EU member states necessary for authorization to place genetically modified plants and derived foods on the market. New Community Regulations are intended to end this moratorium by providing a harmonized and transparent safety assessment, a centralised authorization procedure, extended labelling provisions and a traceability system for genetically modified organisms (GMO) and derived food and feed.

European Music Year 1985.

ERIC Educational Resources Information Center

Alexanderson, Thomas; And Others

1984-01-01

Articles concerning music are included in this newsletter dedicated to cultural venture to be jointly carried out by the Council of Europe and the European communities. Many events will mark Music Year 1985, including concerts, dance performances, operas, publications, recordings, festivals, exhibitions, competitions, and conferences on musical…

Recent Migrants and Education in the European Union

ERIC Educational Resources Information Center

Osadan, Robert; Reid, Elizabeth

2016-01-01

European schools should improve their methods for teaching migrant students. The European Union has been making efforts to meet the needs of migrant students for some time. From the 2009 Eurydice report "Integrating Immigrant Children into Schools in Europe," which suggests measures to foster inclusion in the larger community and…

Legislative and non-legislative regulations concerning Rx drug advertisement in the European Union and the United States--comparative analysis.

PubMed

Czerw, Aleksandra; Religioni, Urszula

2012-01-01

Drug advertising is one of the most popular forms of communication between pharmaceutical companies and prospect drug purchasers. In the face of strong competition on the pharmaceutical market on the one hand, and patient's high susceptibility to various forms of advertising on the other, drug producers try to reach as wide group of recipients as possible. However, proper medicine use requires not only doctor's wide knowledge and experience, but also patient's awareness of necessity of rational drug usage. Advertising activities related to this group of medicines are covered by rigorous law regulations, with taking into account above-mentioned issues, and other specific features of drugs available with prescription. The aim of this article is to present legislative and non-legislative regulations concerning Rx drugs, taking into consideration law regulations that are in force in the European Union and the United States. Ethic codes implemented by drug producers associations were also used.

A European community pharmacy-based survey to investigate patterns of prescription fraud through identification of falsified prescriptions.

PubMed

Lapeyre-Mestre, Maryse; Gony, Mireille; Carvajal, Alfonso; Macias, Diego; Conforti, Anita; D'Incau, Paola; Heerdink, Rob; Van der Stichele, Robert; Bergman, Ulf

2014-01-01

To identify prescription drugs involved in falsified prescriptions in community pharmacies in 6 European countries. A cross-sectional survey among 2,105 community pharmacies in Belgium, France, Italy, the Netherlands, Spain and Sweden was carried out to collect all suspect prescription forms. For each reported drug, the number of reported falsified prescriptions per thousand inhabitants was estimated. A falsification ratio was calculated by dividing the number of reports by the number of defined daily doses per 1,000 inhabitants per day for this drug, computed from national sale or reimbursement data. On 862 prescription forms, benzodiazepines (zolpidem, bromazepam, alprazolam), buprenorphine (as an opioid maintenance drug) and tramadol were the most frequently reported. Depending on their level of use in each country, methylphenidate, morphine and flunitrazepam presented the highest falsification ratios, particularly in Spain, Belgium and France. Stimulants, opioids and some benzodiazepines were the most frequently reported drugs in this survey on falsified prescriptions, but differences between countries were observed. © 2014 S. Karger AG, Basel.

Living Organ Donation by Minors: An Analysis of the Regulations in European Union Member States.

PubMed

Thys, K; Van Assche, K; Nys, H; Sterckx, S; Borry, P

2016-12-01

Living organ donation (LD) is an increasingly established practice. Whereas in the United States and Canada LD by minors has occasionally been reported, LD by minors seems to be largely absent in the European Union (EU). It is currently unclear whether this is the result of a different legal approach. This study is the first to systematically analyze the regulations of EU member states, Norway, and Iceland toward LD by minors. Relevant regulations were identified by searching government websites, translated, compared, and sent for verification to national legal experts. We identified five countries where LD by minors is allowed. In two of these (Belgium and the United Kingdom), some minors may be deemed sufficiently mature to make an autonomous decision regarding LD. In contrast, in the three other countries (Luxembourg, Norway, and Sweden), LD by minors is only allowed subject to parental permission and the assent (or absence of objection) of the donor. Where allowed, regulations differ significantly with regard to the substantive and procedural safeguards in place. In view of the controversial nature of the procedure, as illustrated by recent reports and surveys, we argue for a very cautious approach and greater harmonization in countries where LD by minors is allowed. © Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.

Delivering diversity: newly regulated midwifery returns to Manitoba, Canada, one community at a time.

PubMed

Kreiner, Meta

2009-01-01

Through its publicly funded health care system, Canada is committed to offering accessible, quality maternity health services to all its citizens, yet this remains a challenge in its First Nations, rural and immigrant communities. With the implementation of midwifery as a self-regulating health profession in Manitoba, Canada, in 2000, initiatives were incorporated into the structure of the profession to try to address this issue. This qualitative investigation documents and explores these initiatives through a case study combining semistructured interviews and documentary sources. The innovations discussed include the development of an Aboriginal midwifery degree program, the supports put in place to assist rural midwifery practices, and the efforts to increase ethnic diversity and cultural competence within the midwifery profession. What unites these efforts is a community building approach which attempts to strengthen communities through local midwifery services and midwives drawn from community members.

Environmental Regulation of Microbial Community Structure

NASA Technical Reports Server (NTRS)

Bebout, Leslie; DesMarais, D.; Heyenga, G.; Nelson, F.; DeVincenzi, D. (Technical Monitor)

2002-01-01

Most naturally occurring microbes live in complex microbial communities consisting of thousands of phylotypes of microorganisms living in close proximity. Each of these draws nutrients from the environment and releases metabolic waste products, which may in turn serve as substrates for other microbial groups. Gross environmental changes, such as irradiance level, hydrodynamic flow regime, temperature or water chemistry can directly affect the productivity of some community members, which in turn will affect other dependent microbial populations and rate processes. As a first step towards the development of "standard" natural communities of microorganisms for a variety of potential NASA applications, we are measuring biogeochemical cycling in artificially structured communities of microorganisms, created using natural microbial mat communities as inoculum. The responses of these artificially assembled communities of microorganisms to controlled shifts in ecosystem incubation conditions is being determined. This research requires close linking of environmental monitoring, with community composition in a closed and controlled incubation setting. We are developing new incubation chamber designs to allow for this integrated approach to examine the interplay between environmental conditions, microbial community composition and biogeochemical processes.

THE COMMON MARKET AND EUROPEAN UNIFICATION,

DTIC Science & Technology

A study of the Common Market ; its past problems, current difficulties, and future possibilities are presented. The study consists of seven sections...each of which may be read independently: (1) an introduction to the Common Market ; (2) the Common Market and internal trade; (3) external economic...European Economic Community agriculture; and (7) the Common Market and European political unification. Statistical tables showing import and export data of the Common Market countries are appended. (Author)

European Long-Term Care Programs: Lessons for Community Living Assistance Services and Supports?

PubMed Central

Nadash, Pamela; Doty, Pamela; Mahoney, Kevin J; von Schwanenflugel, Matthias

2012-01-01

Objective To uncover lessons from abroad for Community Living Assistance Services and Supports (CLASS), a federally run voluntary public long-term care (LTC) insurance program created under the Accountable Care Act of 2010. Data Sources Program administrators and policy researchers from Austria, England, France, Germany, and the Netherlands. Study Design Qualitative methods focused on key parameters of cash for care: how programs set benefit levels; project expenditures; control administrative costs; regulate the use of benefits; and protect workers. Data Collection/Extraction Methods Structured discussions were conducted during an international conference of LTC experts, followed by personal meetings and individual correspondence. Principal Findings Germany's self-financing mandate and tight targeting of benefits have resulted in a solvent program with low premiums. Black markets for care are likely in the absence of regulation; France addresses this via a unique system ensuing legal payment of workers. Conclusions Programs in the five countries studied have lessons, both positive and negative, relevant to CLASS design. PMID:22091672

Regulation of Hydrolytic Enzyme Activity in Aquatic Microbial Communities Hosted by Carnivorous Pitcher Plants.

PubMed

Young, Erica B; Sielicki, Jessica; Grothjan, Jacob J

2018-04-20

Carnivorous pitcher plants Sarracenia purpurea host diverse eukaryotic and bacterial communities which aid in insect prey digestion, but little is known about the functional processes mediated by the microbial communities. This study aimed to connect pitcher community diversity with functional nutrient transformation processes, identifying bacterial taxa, and measuring regulation of hydrolytic enzyme activity in response to prey and alternative nutrient sources. Genetic analysis identified diverse bacterial taxa known to produce hydrolytic enzyme activities. Chitinase, protease, and phosphatase activities were measured using fluorometric assays. Enzyme activity in field pitchers was positively correlated with bacterial abundance, and activity was suppressed by antibiotics suggesting predominantly bacterial sources of chitinase and protease activity. Fungi, algae, and rotifers observed could also contribute enzyme activity, but fresh insect prey released minimal chitinase activity. Activity of chitinase and proteases was upregulated in response to insect additions, and phosphatase activity was suppressed by phosphate additions. Particulate organic P in prey was broken down, appearing as increasing dissolved organic and inorganic P pools within 14 days. Chitinase and protease were not significantly suppressed by availability of dissolved organic substrates, though organic C and N stimulated bacterial growth, resulting in elevated enzyme activity. This comprehensive field and experimental study show that pitcher plant microbial communities dynamically regulate hydrolytic enzyme activity, to digest prey nutrients to simpler forms, mediating biogeochemical nutrient transformations and release of nutrients for microbial and host plant uptake.

Trends in pharmacy staff's perception of patient safety in Swedish community pharmacies after re-regulation of conditions.

PubMed

Kälvemark Sporrong, Sofia; Nordén-Hägg, Annika

2014-10-01

All changes in the regulation of pharmacies have an impact on the work carried out in pharmacies and also on patient safety, regardless of whether this is the intention or not. To compare staff apprehension regarding some aspects of patient safety and quality in community pharmacies prior to and after the 2009 changes in regulation of the Swedish community pharmacy market. Questionnaires targeted at pharmacy staff before and after the changes in regulation (in 2008, 2011/12, and 2012/13 respectively) used four identical items, making comparisons of some aspects possible. All four items demonstrated a significant decrease in the first survey after the changes as compared to before. In the second survey significant differences were found on the two items representing safety climate whereas the items representing team climate and management showed no significant differences. The comparison carried out in this study indicates a negative effect in Swedish community pharmacies on safety and quality issues, as experienced by pharmacy staff. It is recommended that the possible effects of healthcare reforms are assessed before implementation, in order to counteract conceivable decline in factors including patient safety and working conditions.

Family Responsibilities: How Are They Shared in European Households?

ERIC Educational Resources Information Center

Statistics in Focus: Population and Social Conditions, 1997

1997-01-01

This newsletter focuses on the division of family responsibilities in European households, which is based on results of the European Community Household Panel, a multi-dimensional survey covering several subjects, including demographic and employment characteristics. The survey was based on a questionnaire adapted by various national data…

Vocational Qualifications in the Member States of the European Community and Moves towards an Open Market. NCVQ R&D Report No. 2. Towards 1992.

ERIC Educational Resources Information Center

Johnson, Ron

This report provides a summary of the education and training arrangements in the 12 member states of the European Community (EC) from school programs to technician and professional training. The introduction traces the history of initiatives and legislation in the EC and its related organizations with respect to qualifications, training, and…

The new European legislation on traditional herbal medicines: main features and perspectives.

PubMed

Silano, Marco; De Vincenzi, Massimo; De Vincenzi, Alessandro; Silano, Vittorio

2004-03-01

Under the Italian Presidency of the Council of the European Union (July 2003-December 2003) an agreement has been reached by the European Parliament and the Council on the approval of the proposal of Directive of the European Parliament and the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products. Once implemented in the E.U. Member States, this new Directive will remove the constraints that have made it difficult granting marketing authorisations of herbal substances and preparations as traditional medicinal products under the pre-existing Community legislation. The main features (i.e. traditional herbal medicine definition, simplified registration procedure, provisions for Community herbal monographs and Community list of herbal substances and preparations and establishment of the Committee for Herbal Medicinal Products) of this new Community legislation are analysed and discussed in the present paper together with some expected positive public health impacts.

The European seismological waveform framework EIDA

NASA Astrophysics Data System (ADS)

Trani, Luca; Koymans, Mathijs; Quinteros, Javier; Heinloo, Andres; Euchner, Fabian; Strollo, Angelo; Sleeman, Reinoud; Clinton, John; Stammler, Klaus; Danecek, Peter; Pedersen, Helle; Ionescu, Constantin; Pinar, Ali; Evangelidis, Christos

2017-04-01

The ORFEUS1 European Integrated Data Archive (EIDA2) federates (currently) 11 major European seismological data centres into a common organisational and operational framework which offers: (a) transparent and uniform access tools, advanced services and products for seismological waveform data; (b) a platform for establishing common policies for the curation of seismological waveform data and the description of waveform data by standardised quality metrics; (c) proper attribution and citation (e.g. data ownership). After its establishment in 2013, EIDA has been collecting and distributing seamlessly large amounts of seismological data and products to the research community and beyond. A major task of EIDA is the on-going improvement of the services, tools and products portfolio in order to meet the increasingly demanding users' requirements. At present EIDA is entering a new operational phase and will become the reference infrastructure for seismological waveform data in the pan-European infrastructure for solid-Earth science: EPOS (European Plate Observing System)3. The EIDA Next Generation developments, initiated within the H2020 project EPOS-IP, will provide a new infrastructure that will support the seismological and multidisciplinary EPOS community facilitating interoperability in a broader context. EIDA NG comprises a number of new services and products e.g.: Routing Service, Authentication Service, WFCatalog, Mediator, Station Book and more in the near future. In this contribution we present the current status of the EIDA NG developments and provide an overview of the usage of the new services and their impact on the user community. 1 www.orfeus-eu.org/ 2 www.orfeus-eu.org/eida/eida.html 3 www.epos-ip.org

Pharmaceutical regulation in 15 European countries review.

PubMed

Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

2016-10-01

In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

Applicability of the Old European Respiratory Society/European Community for Steel and Coal reference equations for spirometry interpretation in Tunisian adult population.

PubMed

El Attar, Mohamed Nour; Hadj Mabrouk, Khaoula; Ben Abdelaziz, Ahmed; Abdelghani, Ahmed; Bousarssar, Mohamed; Limam, Khélifa; Maatoug, Chiraz; Bouslah, Hmida; Charrada, Ameur; Rouatbi, Sonia; Ben Saad, Helmi

2014-01-01

Tunisian pulmonary functional laboratories accept the default settings for reference equations (European Respiratory Society/European Community for Steel and Coal (ERS/ECSC1983) offered by the manufacturer even though adult Tunisian reference equations (Tunisian1995) are available. To compare the spirometric profile of Tunisian subjects, according to the two reference equations. Spirometric data were recorded from 1192 consecutive spirometry procedures in adults aged 18-60 years. Reference values and lower limits of normality (LLN) were calculated using the two reference equations. Applied definitions: large airway obstructive ventilatory defect (LAOVD): ratio between the 1st second expiratory volume and forced vital capacity (FEV1/FVC) < LLN. Small AOVD (SAOVD): FEV1/FVC > LLN and FVC > LLN and maximal midexpiratory flow < LLN. Tendency through a restrictive ventilatory defect (TRVD): FEV1 and FVC < LLN. The spirometric profile, according the two reference equations, was determined. Using Tunisian1995 reference equations, 34%, 7%, 37% and 19% of spirometry records were interpreted as normal, and as having, LAOVD, SAOVD and TRVD, respectively. Using ERS/ECSC1983 reference equations, 85%, 3%, 9% and 2% of spirometry records were interpreted as normal, and as having, LAOVD, SAOVD and TRVD, respectively. Using the ERS/ECSC1983 reference equations, misclassification was worse for LAOVD, for SAOVD and for TRVD, respectively, 68%, 94% and 89%. Our results showed that the use of the old Caucasian reference equations resulted in misinterpretation of spirometry data in a significant proportion of subjects. This could result in inappropriate diagnosis and/or management.

EMSO: European multidisciplinary seafloor observatory

NASA Astrophysics Data System (ADS)

Favali, Paolo; Beranzoli, Laura

2009-04-01

EMSO has been identified by the ESFRI Report 2006 as one of the Research Infrastructures that European members and associated states are asked to develop in the next decades. It will be based on a European-scale network of multidisciplinary seafloor observatories from the Arctic to the Black Sea with the aim of long-term real-time monitoring of processes related to geosphere/biosphere/hydrosphere interactions. EMSO will enhance our understanding of processes, providing long time series data for the different phenomenon scales which constitute the new frontier for study of Earth interior, deep-sea biology and chemistry, and ocean processes. The development of an underwater network is based on past EU projects and is supported by several EU initiatives, such as the on-going ESONET-NoE, aimed at strengthening the ocean observatories' scientific and technological community. The EMSO development relies on the synergy between the scientific community and industry to improve European competitiveness with respect to countries such as USA, Canada and Japan. Within the FP7 Programme launched in 2006, a call for Preparatory Phase (PP) was issued in order to support the foundation of the legal and organisational entity in charge of building up and managing the infrastructure, and coordinating the financial effort among the countries. The EMSO-PP project, coordinated by the Italian INGV with participation by 11 institutions from as many European countries, started in April 2008 and will last four years.

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

PubMed Central

2014-01-01

Background Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied. Methods Data on all designated orphan drugs, their indication, MA, PIPs and indication group (adult or child) were obtained from the European Medicines Agency (EMA). The outcome and duration of the process from orphan drug designation (ODD) to MA, was compared, per indication, by age group. The effect of the Paediatric Drug Regulation, implemented in 2007, on the application process was assessed with survival analysis. Results Eighty-one orphan drugs obtained MA since 2000 and half are authorised for (a subgroup of) children; another 34 are currently undergoing further investigations in children through agreed PIPs. The Paediatric Drug Regulation did not significantly increase the number of ODDs with potential paediatric indications (58% before vs 64% after 2007 of ODDs, p = 0.1) and did not lead to more MAs for ODs with paediatric indications (60% vs 43%, p = 0.22). ODs authorised after 2007 had a longer time to MA than those authorised before 2007 (Hazard ratio (95% CI) 2.80 (1.84-4.28), p < 0.001); potential paediatric use did not influence the time to MA (Hazard ratio (95% CI) 1.14 (0.77-1.70), p = 0.52). Conclusions The EU Paediatric Drug Regulation had a minor impact on development and availability of ODs for children, was associated with a longer time to MA, but ensured the further paediatric development of drugs still off-label to children. The impact of the Paediatric Drug Regulation on research quantity and quality in children through PIPs is not yet clear. PMID

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children.

PubMed

Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H; de Vries, Peter J

2014-08-05

Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied. Data on all designated orphan drugs, their indication, MA, PIPs and indication group (adult or child) were obtained from the European Medicines Agency (EMA). The outcome and duration of the process from orphan drug designation (ODD) to MA, was compared, per indication, by age group. The effect of the Paediatric Drug Regulation, implemented in 2007, on the application process was assessed with survival analysis. Eighty-one orphan drugs obtained MA since 2000 and half are authorised for (a subgroup of) children; another 34 are currently undergoing further investigations in children through agreed PIPs. The Paediatric Drug Regulation did not significantly increase the number of ODDs with potential paediatric indications (58% before vs 64% after 2007 of ODDs, p = 0.1) and did not lead to more MAs for ODs with paediatric indications (60% vs 43%, p = 0.22). ODs authorised after 2007 had a longer time to MA than those authorised before 2007 (Hazard ratio (95% CI) 2.80 (1.84-4.28), p < 0.001); potential paediatric use did not influence the time to MA (Hazard ratio (95% CI) 1.14 (0.77-1.70), p = 0.52). The EU Paediatric Drug Regulation had a minor impact on development and availability of ODs for children, was associated with a longer time to MA, but ensured the further paediatric development of drugs still off-label to children. The impact of the Paediatric Drug Regulation on research quantity and quality in children through PIPs is not yet clear.

Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.

PubMed

Permanand, Govin; Mossialos, Elias; McKee, Martin

2006-01-01

Following a review process lasting almost four years, and culminating in several pieces of new European legislation, adjustments have been made to the European Union's (EU) regulatory framework for pharmaceuticals. The European Commission laid out its priorities for the review as: simplifying the authorisation system, ensuring a high quality of public health, completing the internal market in medicines, and preparing for the enlargement of the Union. Amongst the most important changes brought about by the new rules are those relating to the European drug approval procedures, the functions and operational transparency of the European Medicines Agency (EMEA), and the EU's pharmacovigilance system. This article provides a brief examination of key elements of these changes, and considers the extent to which they serve the goal of improved public health protection within the EU.

Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management.

PubMed

Martini, Daniela; Biasini, Beatrice; Rossi, Stefano; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

2018-06-01

All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

TELRI: Trans European Language Resources Infrastructure Newsletter, 1995-1997.

ERIC Educational Resources Information Center

TELRI: Trans European Language Resources Infrastructure Newsletter, 1997

1997-01-01

The first seven issues of the Trans European Language Resources Infrastructure (TELRI) newsletter, a publication of the COPERNICUS project funded by the Commission of the European Communities, date from September 1995 to October 1997. The first three issues contain articles in the origins of TELRI, its members, working groups, and events. TELRI's…

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function

PubMed Central

Cortelazzi, Chiara; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Vitale, Marco; Bonadonna, Riccardo C.; Di Nuzzo, Sergio; De Felici, Maria Beatrice

2017-01-01

Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims. PMID:29271939

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function.

PubMed

Martini, Daniela; Angelino, Donato; Cortelazzi, Chiara; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Di Nuzzo, Sergio; De Felici, Maria Beatrice; Del Rio, Daniele

2017-12-22

Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims.

Suggesting a new European language policy.

PubMed

Nelde, Peter H

2004-01-01

Conflict is the most intriguing aspect of contact linguistics. Throughout history ever since the Tower of Babel was left unfinished, contacts between speakers of different languages have unavoidably resulted in conflicts between speakers of those languages. Without any doubt, the European Union (EU)--above all after the decision to enlarge the community--has accepted the multidisciplinary symbolic function of language and culture as a basis for European political unification. Accordingly, European Union policy makers have had to analyze conflicts caused by monolingualism and multilingualism, all aspects of contact linguistics. Can these conflicts be solved, minimized or neutralized by strategies of language planning, language policies and language politics? Initial results of European language policy strategies permit at least a cautious measure of optimism and open broad perspectives for the future of a New Multilingualism which will be discussed in our contribution.

Current Status of Legislation on Dietary Products for Sportspeople in a European Framework.

PubMed

Martínez-Sanz, José Miguel; Sospedra, Isabel; Baladía, Eduard; Arranz, Laura; Ortiz-Moncada, Rocío; Gil-Izquierdo, Angel

2017-11-08

The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids.

The Italian regulation on Assisted Reproductive Technologies facing the European Court of Human Rights: the case of Costa and Pavan v. Italy.

PubMed

Penasa, Simone

2012-01-01

This article will describe the current legal framework on Assisted Reproduction Technology (ART) regulation in Italy, taking into account recent case-law derived from the implementation of the Law 40 of 2004 on ART. Special attention will be devoted to the case of Costa and Pavan v. Italy, recently decided by the Tenth Session of the European Court of Human Rights (ECtHR). In that decision, the European Court declared the incompatibility of the ban to pre-implantation genetic diagnosis introduced by the abovementioned Italian law on ART. The case will be analysed from a dual perspective. On the one hand, it will be considered in the light of the ECtHR case-law, in order to derive systematic aspects of continuity or discontinuity between the former and the latter2. On the other hand, the case will be considered in the light of its concrete and prospective impact on the Italian legal approach to ART regulation, considering especially the direct and indirect influence of the case: e.g., its possible utilisation by Italian judges when they are called upon to implement Law 40.

The Development of a European Dimension in the Training of Guidance Practitioners.

ERIC Educational Resources Information Center

CEDEFOP Flash, 1993

1993-01-01

CEDEFOP's (European Centre for the Development of Vocational Training) work on the development of the European dimension in the training of vocational guidance practitioners took place in two stages. The first was the survey of the work and training of guidance practitioners in each Member State of the European Community. Findings indicated…

The Russian-European Union Competition in Ukraine

DTIC Science & Technology

2015-06-01

of Germany’s brief triumph during the Great War. The 1918 treaty of Brest -Litovsk created for the first time an independent Ukraine, designed to be a...6North Atlantic Treaty Organization, “Founding Act on Mutual Relations, Cooperation and Security between NATO and the Russian Federation signed in Paris ...institution now known as the European Union originated as the European Coal and Steel Community in 1951. Interest in expanding economic cooperation

Envri Cluster - a Community-Driven Platform of European Environmental Researcher Infrastructures for Providing Common E-Solutions for Earth Science

NASA Astrophysics Data System (ADS)

Asmi, A.; Sorvari, S.; Kutsch, W. L.; Laj, P.

2017-12-01

European long-term environmental research infrastructures (often referred as ESFRI RIs) are the core facilities for providing services for scientists in their quest for understanding and predicting the complex Earth system and its functioning that requires long-term efforts to identify environmental changes (trends, thresholds and resilience, interactions and feedbacks). Many of the research infrastructures originally have been developed to respond to the needs of their specific research communities, however, it is clear that strong collaboration among research infrastructures is needed to serve the trans-boundary research requires exploring scientific questions at the intersection of different scientific fields, conducting joint research projects and developing concepts, devices, and methods that can be used to integrate knowledge. European Environmental research infrastructures have already been successfully worked together for many years and have established a cluster - ENVRI cluster - for their collaborative work. ENVRI cluster act as a collaborative platform where the RIs can jointly agree on the common solutions for their operations, draft strategies and policies and share best practices and knowledge. Supporting project for the ENVRI cluster, ENVRIplus project, brings together 21 European research infrastructures and infrastructure networks to work on joint technical solutions, data interoperability, access management, training, strategies and dissemination efforts. ENVRI cluster act as one stop shop for multidisciplinary RI users, other collaborative initiatives, projects and programmes and coordinates and implement jointly agreed RI strategies.

The European network of Biosafety-Level-4 laboratories: enhancing European preparedness for new health threats.

PubMed

Nisii, C; Castilletti, C; Di Caro, A; Capobianchi, M R; Brown, D; Lloyd, G; Gunther, S; Lundkvist, A; Pletschette, M; Ippolito, G

2009-08-01

Emerging and re-emerging infections and possible bioterrorism acts will continue to challenge both the medical community and civilian populations worldwide, urging health authorities to respond rapidly and effectively. Established in 2005, the European Community (EC)-funded European Network of Biosafety-Level-4 laboratories (Euronet-P4), which brings together the laboratories in Porton Down, London, Hamburg, Marburg, Solna, Lyon and Rome, seeks to increase international collaboration in the areas of high containment laboratory biosafety and viral diagnostic capability, to strengthen Europe's capacity to respond to an infectious disease emergency, and to offer assistance to countries not equipped with such costly facilities. Network partners have agreed on a common strategy to fill the gaps identified in the field of risk group-4 agents' laboratory diagnosis, namely the lack of standardization and of reference samples. The network has received a further 3-year funding, to offer assistance to external laboratories, and to start the planning of field activities.

EU orphan regulation--ten years of application.

PubMed

Michaux, Geneviève

2010-01-01

In April 2000, European Regulation (EC) No 141/2000 on Orphan Medicinal Products, which, following the U.S. example, had been adopted to boost the research, development, and marketing of medicinal products for rare diseases, became effective. Ten years later, figures prove that, with an average of more than 70 orphan designations per year, the European orphan regulation is a success. To date, the key issue is no longer research and development but effective market access. Less than 10% of the orphan designated products are approved for marketing and even less products are actually placed on the European national markets due to pricing and reimbursement obstacles. The article examines the European orphan regime, focusing on its two cornerstones--orphan designation and exclusivity--and highlighting the concepts that are still unclear and the issues that have not yet been addressed. The European Orphan Regulation has been proved to work well, but it would be even more successful if orphan designation was easier and orphan incentives were more attractive. The article concludes on the changes to be made to the European orphan legal regime that would encourage even more the research and development of orphan products.

Epidemiology of European Community-Associated Methicillin-Resistant Staphylococcus aureus Clonal Complex 80 Type IV Strains Isolated in Denmark from 1993 to 2004▿

PubMed Central

Larsen, A. R.; Böcher, S.; Stegger, M.; Goering, R.; Pallesen, L. V.; Skov, R.

2008-01-01

In Europe, community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections have been caused predominantly by isolates belonging to the “European CA-MRSA” clone (sequence type 80, staphylococcal cassette chromosome mec type IV). In this study, the epidemiology of European CA-MRSA was investigated on a nationwide scale, covering the period from 1993 to 2004. Denmark has been a low-prevalence country regarding MRSA since the mid-1970s but has experienced an increase in the number of new MRSA cases in recent years. Our results show that European CA-MRSA contributed to this increase. The isolates primarily caused skin and soft tissue infections (SSTIs) in patients outside hospitals, and transmission between household members was the predominant mode of spread. Although some of the isolates were found in hospitalized patients, nosocomial transmission seemed likely in only one instance, pointing to endogenous infections as an important factor. Compared to the CA-MRSA clone most common in the United States (USA300), the European CA-MRSA clone seems less well adapted to persist in hospital environments. Patients with a recent history of travel or family relation to the Mediterranean or Middle East were highly overrepresented. The epidemiological data indicated that the European CA-MRSA isolates were introduced into Denmark on multiple occasions, paralleled by an increasing level of genetic diversity of the isolates found during the study period. European CA-MRSA has previously been described as a rather uniform clone. However, we found pronounced, diverse pulsed-field gel electrophoresis subtypes, staphylococcal protein A gene (spa) types, and susceptibility patterns. PMID:17989197

The 2011 PHARMINE report on pharmacy and pharmacy education in the European Union

PubMed Central

Atkinson, Jeffrey; Rombaut, Bart

The PHARMINE consortium consists of 50 universities from European Union member states or other European countries that are members of the European Association of Faculties of Pharmacy (EAFP). EU partner associations representing community (PGEU), hospital (EAHP) and industrial pharmacy (EIPG), together with the European Pharmacy Students’ Association (EPSA) are also part of the consortium. The consortium surveyed pharmacies and pharmacists in different settings: community, hospital, industry and other sectors. The consortium also looked at how European Union higher education institutions and courses are organised. The PHARMINE survey of pharmacy and pharmacy education in Europe produced country profiles with extensive information for EU member states and several other European countries. These data are available at: http://www.pharmine.org/losse_paginas/Country_Profiles/. This 2011 PHARMINE report presents the project and data, and some preliminary analysis on the basic question of how pharmacy education is adapted to pharmacy practice in the EU. PMID:24198854

Evidence based policy making in the European Union: the role of the scientific community.

PubMed

Majcen, Špela

2017-03-01

In the times when the acquis of the European Union (EU) has developed so far as to reach a high level of technical complexity, in particular in certain policy fields such as environmental legislation, it is important to look at what kind of information and data policy decisions are based on. This position paper looks at the extent to which evidence-based decision-making process is being considered in the EU institutions when it comes to adopting legislation in the field of environment at the EU level. The paper calls for closer collaboration between scientists and decision-makers in view of ensuring that correct data is understood and taken into consideration when drafting, amending, negotiating and adopting new legal texts at all levels of the EU decision-making process. It concludes that better awareness of the need for such collaboration among the decision-makers as well as the scientific community would benefit the process and quality of the final outcomes (legislation).

European Union pharmacovigilance capabilities: potential for the new legislation

PubMed Central

Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

2015-01-01

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed. PMID:26301067

The Role of the Two Sides of Industry in Initial and Continuing Training. Documentation of the Conference Organized by the European Centre for the Development of Vocational Training (CEDEFOP) in Collaboration with the Commission of the European Communities and the Economic and Social Committee of the EC (Brussels, Belgium, November 8-9, 1988).

ERIC Educational Resources Information Center

European Centre for the Development of Vocational Training, Berlin (West Germany).

This document reports the proceedings of a conference held in Brussels to take stock (on the basis of the studies conducted by the European Centre for the Development of Vocational Training and the analyses carried out in this field in all the European Community member states) of the work undertaken in the last few years and to present…

Geometric design practices for European roads

DOT National Transportation Integrated Search

2001-06-01

The objective of the scanning tour was to review and document European procedures and practices in roadway geometric design and context-sensitive design, in which a balance is sought between safety and mobility needs and community interests. The U.S....

Does deregulation in community pharmacy impact accessibility of medicines, quality of pharmacy services and costs? Evidence from nine European countries.

PubMed

Vogler, Sabine; Habimana, Katharina; Arts, Danielle

2014-09-01

To analyse the impact of deregulation in community pharmacy on accessibility of medicines, quality of pharmacy services and costs. We analysed and compared community pharmacy systems in five rather deregulated countries (England, Ireland, the Netherlands, Norway, Sweden) and four rather regulated countries (Austria, Denmark, Finland, Spain). Data were collected by literature review, a questionnaire survey and interviews. Following a deregulation, several new pharmacies and dispensaries of Over-the-Counter (OTC) medicines tended to be established, predominantly in urban areas. Unless prevented by regulation, specific stakeholders, e.g. wholesalers, were seen to gain market dominance which limited envisaged competition. There were indications for an increased workload for pharmacists in some deregulated countries. Economic pressure to increase the pharmacy turnover through the sale of OTC medicines and non-pharmaceuticals was observed in deregulated and regulated countries. Prices of OTC medicines were not found to decrease after a deregulation in pharmacy. Access to pharmacies usually increases after a deregulation but this is likely to favour urban populations with already good accessibility. Policy-makers are recommended to take action to ensure equitable accessibility and sustainable competition in a more deregulated environment. No association between pharmaceutical expenditure and the extent of regulation/deregulation appears to exist. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Sunglasses, the European directive and the European standard.

PubMed

Dain, Stephen John; Ngo, Thi Phuong Thao; Cheng, Brian Barry; Hu, Angel; Teh, Adrian Ghim Boon; Tseng, Jane; Vu, Nam

2010-05-01

The Optics and Radiometry Laboratory (ORLAB) provides a testing service for the Australian sunglass industry to assist its compliance with the mandatory Consumer Product Safety Standard. In doing so, a number of sunglasses carrying the CE mark (in effect a claim of compliance with the European Union Personal Protective Equipment Directive) have been tested. Since there is no mandatory testing in Europe (the sunglass industry is deemed self regulating), evaluating their performance will give an insight into compliance with the Directive. Consecutive submissions to ORLAB over a period of 18 months were examined for CE marked sunglasses. The results for 646 CE marked pairs of sunglasses tested during 2003 and first half 2004 were examined and evaluated for compliance with EN 1836 (the European sunglass standard) on the basis of refractive power, prismatic power, transmittance (visible, UV and coloration) and polarization. A total of 17.3% failed EN 1836 and 3.3% were borderline (i.e. within our uncertainties of measurement of the requirement). The failures comprised: 0.9% lens defect; 12.5% polarization alignment error; 2.7% excessive vertical prism; 22.3% excessive horizontal prism; 27.7% excessive spherical power; 14.3% excessive cylindrical power; 1.8% excessive UV transmittance; and 23.2% transmittance difference between lenses (always gradient tints). With up to 20% non-compliance, self regulation is not working particularly well in providing the public with complying sunglasses.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

PubMed

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply

Education and European integration

NASA Astrophysics Data System (ADS)

Lowe, John

1992-11-01

The main purpose of this article is to discuss the implications for education and training of the movement towards integration in Europe in the historic context of the creation of a single market within the European Community (EC) and the end of the Communist regimes in Central and Eastern Europe. The experience of the EC is used to illustrate trends and problems in the development of international cooperation in education and training. Common concerns and priorities throughout the new Europe are then identified and discussed. These include the pursuit of quality in schooling, efforts to serve the interests of disadvantaged learners, and the treatment of European Studies in the curriculum, including the improvement of the teaching of foreign languages.

Use of fused deposit modeling for additive manufacturing in hospital facilities: European certification directives.

PubMed

Otero, Joel J; Vijverman, An; Mommaerts, Maurice Y

2017-09-01

The goal of this study was to identify current European Union regulations governing hospital-based use of fused deposit modeling (FDM), as implemented via desktop three-dimensional (3D) printers. Literature and Internet sources were screened, searching for official documents, regulations/legislation, and views of specialized attorneys or consultants regarding European regulations for 3D printing or additive manufacturing (AM) in a healthcare facility. A detailed review of the latest amendment (2016) of the European Parliament and Council legislation for medical devices and its classification was performed, which has regularly updated published guidelines for medical devices, that are classified by type and duration of patient contact. As expected, regulations increase in accordance with the level (I-III) of classification. Custom-made medical devices are subject to different regulations than those controlling serially mass-produced items, as originally specified in 98/79/EC European Parliament and Council legislation (1993) and again recently amended (2016). Healthcare facilities undertaking in-house custom production are not obliged to fully follow the directives as stipulated, given an exception for this scenario (Article 4.4a, 98/79/EC). Patient treatment and diagnosis with the aid of customized 3D printing in a healthcare facility can be performed without fully meeting the European Parliament and Council legislation if the materials used are ISO 10993 certified and article 4.4a applies. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Wspolnoty Europejskie wobec problemow jezykowych (Addressing Language Problems in the European Communities).

ERIC Educational Resources Information Center

Zelazny, Walter

2003-01-01

Raises questions about the a European Union commissioned report titled "Les Europeens et les langues," which was prepared in accordance with the customary routine used for a series of report on European public opinion. Issues discussed include the omission of several languages, the use of Esperanto, the languages reportedly used by…

The european paediatric legislation: benefits and perspectives

PubMed Central

2010-01-01

Background The lack of availability of appropriate medicines for children is an extensive and well known problem. Paediatricians and Physicians who take care of the paediatric population are primarily exposed to cope with this negative situation very often as more than half of the children are prescribed off-label or unlicensed medicines. Discussion Medicinal products used to treat this population should be subjected to ethical research of high quality and be explicitly authorised for use in children as it happens in adults. For that reason, and following the US experience, the European Paediatric Regulation has been amended in January 2007 by the European Commission. The objective of the Paediatric Regulation is to improve the development of high quality and ethically researched medicines for children aged 0 to 17 years, to facilitate the availability of information on the use of medicines for children, without subjecting children to unnecessary trials, or delaying the authorisation of medicines for use in adults. Summary The Paediatric Regulation is dramatically changing the regulatory environment for paediatric medicines in Europe and is fuelling an increased number of clinical trials in the paediatric population. Nevertheless, there are some risks and pitfalls that need to be anticipated and controlled in order to ensure that children will ultimately benefit from this European initiative. PMID:20716337

Emotion regulation and well-being in primary classrooms situated in low-socioeconomic communities.

PubMed

Somerville, Matthew P; Whitebread, David

2018-04-14

Although emotion is central to most models of children's well-being, few studies have looked at how well-being is related to the ways in which children regulate their emotions. The aim of this study was to examine the associations among children's emotion regulation strategy choice and their emotional expression, behaviour, and well-being. The study also investigated whether contextual factors influenced the emotion regulation strategies children chose to use. Participants (N = 33) were selected from four Year 5/6 composite classrooms situated in low-socioeconomic urban communities in New Zealand. Questionnaires were used to measure children's well-being and teacher-reported emotional and behavioural problems. Emotional expression and emotion regulation strategies were measured through video-recorded observations in the classroom. A total of 1,184 instances of emotion regulation strategy use were coded using a framework based on Gross' process model of emotion regulation. The findings highlight the complexity of the relations among emotion regulation, emotion expression, and well-being. Some strategies, such as Cognitive Reappraisal, were effective at upregulating negative emotion in the short term, yet not strongly associated with well-being. Others, such as Situation Modification: Physical, were positively associated with well-being, yet not with an immediate change in a child's emotional experience. The findings also suggest children flexibly use different strategies in relation to different contextual demands. These findings may be used to guide future intervention efforts which target emotion regulation strategy use as well as those which focus on teachers' support of children during emotionally challenging situations. © 2018 The British Psychological Society.

Current Status of Legislation on Dietary Products for Sportspeople in a European Framework

PubMed Central

Arranz, Laura; Ortiz-Moncada, Rocío

2017-01-01

The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids. PMID:29117104

Is the European pediatric medicine regulation working for children and adolescents with cancer?

PubMed

Vassal, Gilles; Geoerger, Birgit; Morland, Bruce

2013-03-15

The European Pediatric Medicine Regulation was launched in 2007 to provide better medicines for children. Five years later, the number of new anticancer drugs in early development in the pediatric population remains low, and most children with cancer are still largely denied access to innovative drugs in Europe, as compared with the United States. We analyzed individual pediatric investigation plan (PIP) and waiver decisions for oncology drugs and all oncology drugs that have been approved for marketing authorization since 2007 in Europe. Among the 45 approved PIPs, 33% concern leukemias and lymphomas, 29% solid tumors, 13% brain tumors, and 20% a drug for supportive care. No specific PIP exists for life-threatening diseases such as high-risk neuroblastoma, whereas there are several PIPs in extremely rare malignancies in children and adolescents such as gastrointestinal stromal tumor, melanoma, thyroid cancer, and chronic myeloid leukemia. This paradoxical situation is due to approval of a PIP being driven by the adult indication. Twenty-six of 28 authorized new oncology drugs have a potentially relevant mechanism of action for pediatric malignancies, but 50% have been waived because the adult condition does not occur in children. The most striking example is crizotinib. Implementation of the pediatric regulation should no longer be driven by the adult indication but should be guided instead by the biology of pediatric tumors and the mechanism of action of a drug. This change will be achievable through voluntary PIPs submitted by Pharma or revocation of the oncology class waiver list.

Emotion Regulation Difficulties, Youth-Adult Relationships, and Suicide Attempts Among High School Students in Underserved Communities

PubMed Central

Pisani, Anthony R.; Wyman, Peter A.; Petrova, Mariya; Schmeelk-Cone, Karen; Goldston, David B.; Xia, Yinglin; Gould, Madelyn S.

2013-01-01

To develop and refine interventions to prevent youth suicide, knowledge is needed about specific processes that reduce risk at a population level. Using a cross-sectional design, the present study tested hypotheses regarding associations between self-reported suicide attempts, emotion regulation difficulties, and positive youth-adult relationships among 7,978 high-school students (48.6% male, 49.9% female) in 30 high schools from predominantly rural, low-income communities. 683 students (8.6%) reported a past-year suicide attempt. Emotion regulation difficulties and a lack of trusted adults at home and school were associated with increased risk for making a past-year suicide attempt, above and beyond the effects of depressive symptoms and demographic factors. The association between emotion regulation difficulties and suicide attempts was modestly lower among students who perceived themselves as having higher levels of trusted adults in the family, consistent with a protective effect. Having a trusted adult in the community (outside of school and family) was associated with fewer suicide attempts in models that controlled only for demographic covariates, but not when taking symptoms of depression into account. These findings point to adolescent emotion regulation and relationships with trusted adults as complementary targets for suicide prevention that merit further intervention studies. Reaching these targets in a broad population of adolescents will require new delivery systems and “option rich” intervention designs. PMID:23666604

Emotion regulation difficulties, youth-adult relationships, and suicide attempts among high school students in underserved communities.

PubMed

Pisani, Anthony R; Wyman, Peter A; Petrova, Mariya; Schmeelk-Cone, Karen; Goldston, David B; Xia, Yinglin; Gould, Madelyn S

2013-06-01

To develop and refine interventions to prevent youth suicide, knowledge is needed about specific processes that reduce risk at a population level. Using a cross-sectional design, the present study tested hypotheses regarding associations between self-reported suicide attempts, emotion regulation difficulties, and positive youth-adult relationships among 7,978 high-school students (48.6% male, 49.9% female) in 30 high schools from predominantly rural, low-income communities. 683 students (8.6%) reported a past-year suicide attempt. Emotion regulation difficulties and a lack of trusted adults at home and school were associated with increased risk for making a past-year suicide attempt, above and beyond the effects of depressive symptoms and demographic factors. The association between emotion regulation difficulties and suicide attempts was modestly lower among students who perceived themselves as having higher levels of trusted adults in the family, consistent with a protective effect. Having a trusted adult in the community (outside of school and family) was associated with fewer suicide attempts in models that controlled only for demographic covariates, but not when taking symptoms of depression into account. These findings point to adolescent emotion regulation and relationships with trusted adults as complementary targets for suicide prevention that merit further intervention studies. Reaching these targets in a broad population of adolescents will require new delivery systems and "option rich" (OR) intervention designs.

[Advanced therapy: from European regulatory framework to national regulatory framework].

PubMed

Lucas-Samuel, S

2013-05-01

The European regulation n(o) 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law n(o) 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the "hospital exemption" framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the n(o) 2012-1236 decree published on the 6th of November 2012. Copyright © 2013. Published by Elsevier SAS.

Evaluating a European knowledge hub on climate change in agriculture: Are we building a better connected community?

PubMed

Saetnan, Eli Rudinow; Kipling, Richard Philip

In order to maintain food security and sustainability of production under climate change, interdisciplinary and international collaboration in research is essential. In the EU, knowledge hubs are important funding instruments for the development of an interconnected European Research Area. Here, network analysis was used to assess whether the pilot knowledge hub MACSUR has affected interdisciplinary collaboration, using co-authorship of peer reviewed articles as a measure of collaboration. The broad community of all authors identified as active in the field of agriculture and climate change was increasingly well connected over the period studied. Between knowledge hub members, changes in network parameters suggest an increase in collaborative interaction beyond that expected due to network growth, and greater than that found in the broader community. Given that interdisciplinary networks often take several years to have an impact on research outputs, these changes within the relatively new MACSUR community provide evidence that the knowledge hub structure has been effective in stimulating collaboration. However, analysis showed that knowledge hub partners were initially well-connected, suggesting that the initiative may have gathered together researchers with particular resources or inclinations towards collaborative working. Long term, consistent funding and ongoing reflection to improve networking structures may be necessary to sustain the early positive signs from MACSUR, to extend its success to a wider community of researchers, or to repeat it in less connected fields of science. Tackling complex challenges such as climate change will require research structures that can effectively support and utilise the diversity of talents beyond the already well-connected core of scientists at major research institutes. But network research shows that this core, well-connected group are vital brokers in achieving wider integration.

The Emergence and Institutionalisation of the European Higher Education and Research Area

ERIC Educational Resources Information Center

Beerkens, Eric

2008-01-01

Since the European unification project started in the 1950s, rules, regulations and policies have been formulated by the European Union (and its predecessors) to facilitate the flow of products and people; those who benefited from the increasing transnational exchange urged European actors to remove remaining obstacles and further facilitate…

Global health in the European Union--a review from an agenda-setting perspective.

PubMed

Aluttis, Christoph; Krafft, Thomas; Brand, Helmut

2014-01-01

This review attempts to analyse the global health agenda-setting process in the European Union (EU). We give an overview of the European perspective on global health, making reference to the developments that led to the EU acknowledging its role as a global health actor. The article thereby focuses in particular on the European interpretation of its role in global health from 2010, which was formalised through, respectively, a European Commission Communication and European Council Conclusions. Departing from there, and based on Kingdon's multiple streams theory on agenda setting, we identify some barriers that seem to hinder the further establishment and promotion of a solid global health agenda in the EU. The main barriers for creating a strong European global health agenda are the fragmentation of the policy community and the lack of a common definition for global health in Europe. Forwarding the agenda in Europe for global health requires more clarification of the common goals and perspectives of the policy community and the use of arising windows of opportunity.

European Code against Cancer 4th Edition: Environment, occupation and cancer.

PubMed

Espina, Carolina; Straif, Kurt; Friis, Søren; Kogevinas, Manolis; Saracci, Rodolfo; Vainio, Harri; Schüz, Joachim

2015-12-01

People are exposed throughout life to a wide range of environmental and occupational pollutants from different sources at home, in the workplace or in the general environment - exposures that normally cannot be directly controlled by the individual. Several chemicals, metals, dusts, fibres, and occupations have been established to be causally associated with an increased risk of specific cancers, such as cancers of the lung, skin and urinary bladder, and mesothelioma. Significant amounts of air pollutants - mainly from road transport and industry - continue to be emitted in the European Union (EU); an increased occurrence of lung cancer has been attributed to air pollution even in areas below the EU limits for daily air pollution. Additionally, a wide range of pesticides as well as industrial and household chemicals may lead to widespread human exposure, mainly through food and water. For most environmental pollutants, the most effective measures are regulations and community actions aimed at reducing and eliminating the exposures. Thus, it is imperative to raise awareness about environmental and occupational carcinogens in order to motivate individuals to be proactive in advocating protection and supporting initiatives aimed at reducing pollution. Regulations are not homogeneous across EU countries, and protective measures in the workplace are not used consistently by all workers all the time; compliance with regulations needs to be continuously monitored and enforced. Therefore, the recommendation on Environment and Occupation of the 4th edition of the European Code against Cancer, focusing on what individuals can do to reduce their cancer risk, reads: "In the workplace, protect yourself against cancer-causing substances by following health and safety instructions." Copyright © 2015 International Agency for Research on Cancer. Published by Elsevier Ltd. All rights reserved.

7 CFR 301.91 - Quarantine and regulations; restrictions on interstate movement of regulated articles. 1

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 5 2012-01-01 2012-01-01 false Quarantine and regulations; restrictions on interstate... QUARANTINE NOTICES European Larch Canker Quarantine and Regulations § 301.91 Quarantine and regulations... to stop and inspect persons and means of conveyance, and to seize, quarantine, treat, apply other...

7 CFR 301.91 - Quarantine and regulations; restrictions on interstate movement of regulated articles. 1

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 5 2010-01-01 2010-01-01 false Quarantine and regulations; restrictions on interstate... QUARANTINE NOTICES European Larch Canker Quarantine and Regulations § 301.91 Quarantine and regulations... to stop and inspect persons and means of conveyance, and to seize, quarantine, treat, apply other...

7 CFR 301.91 - Quarantine and regulations; restrictions on interstate movement of regulated articles. 1

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 5 2014-01-01 2014-01-01 false Quarantine and regulations; restrictions on interstate... QUARANTINE NOTICES European Larch Canker Quarantine and Regulations § 301.91 Quarantine and regulations... to stop and inspect persons and means of conveyance, and to seize, quarantine, treat, apply other...

7 CFR 301.91 - Quarantine and regulations; restrictions on interstate movement of regulated articles. 1

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 5 2011-01-01 2011-01-01 false Quarantine and regulations; restrictions on interstate... QUARANTINE NOTICES European Larch Canker Quarantine and Regulations § 301.91 Quarantine and regulations... to stop and inspect persons and means of conveyance, and to seize, quarantine, treat, apply other...

7 CFR 301.91 - Quarantine and regulations; restrictions on interstate movement of regulated articles. 1

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 5 2013-01-01 2013-01-01 false Quarantine and regulations; restrictions on interstate... QUARANTINE NOTICES European Larch Canker Quarantine and Regulations § 301.91 Quarantine and regulations... to stop and inspect persons and means of conveyance, and to seize, quarantine, treat, apply other...

Reviving the Mediterranean Olive Community

ERIC Educational Resources Information Center

Zaferatos, Nicholas C.

2011-01-01

This article presents the findings of a collaborative investigation by six nongovernment organisations (NGOs) from five European-Mediterranean countries to identify a framework for reversing rural marginalisation in Mediterranean communities through sustainable forms of community-based agricultural development. The project brought together…

Vocational Training in the European Community 1995. Annual Report.

ERIC Educational Resources Information Center

European Centre for the Development of Vocational Training, Thessaloniki (Greece).

During 1995, the European Centre for the Development of Vocational Training (CEDEFOP) was moved from Berlin, Germany, to Thessaloniki, Greece. Despite the burdens of the move, progress was made in the following activities: publishing updated CEDEFOP monographs in a variety of official languages; creating a new network for research cooperation on…

7 CFR 301.91-3 - Regulated areas.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., DEPARTMENT OF AGRICULTURE DOMESTIC QUARANTINE NOTICES European Larch Canker Quarantine and Regulations § 301..., in which European larch canker has been found by an inspector or in which the Deputy Administrator has reason to believe that European larch canker is present, or any portion of a quarantined State...

Professional Mobility and the Mutual Recognition of Qualifications in the European Union: Two Institutional Approaches.

ERIC Educational Resources Information Center

Blitz, Brad K.

1999-01-01

Examines the role of transnational institutions (particularly the European Commission and committees of the European Parliament) in facilitating the mutual recognition of professional qualifications among members of the European Economic Community (EEC). Discusses relevant EEC directives, varying compliance among nations, and six cases of citizen…

Legislative regulation and ethical governance of medical research in different European Union countries.

PubMed

Veerus, Piret; Lexchin, Joel; Hemminki, Elina

2014-06-01

To obtain information about the similarities and differences in regulating different types of medical research in the European Union (EU). Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010. In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees (RECs) in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries. There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

COMMUNITY VIOLENCE AND EXTERNALIZING PROBLEMS: MODERATING EFFECTS OF RACE AND RELIGIOSITY IN EMERGING ADULTHOOD

PubMed Central

Fowler, Patrick J.; Ahmed, Sawssan R.; Tompsett, Carolyn J.; Jozefowicz-Simbeni, Debra M. H.; Toro, Paul A.

2009-01-01

The present study examined racial differences in the relationship between exposure to community violence and public and private religiosity in predicting externalizing problems among at-risk emerging adults. Participants were 178 African American and 163 European American emerging adults at risk for exposure to community violence. Exposure to community violence related to more externalizing problems. Greater public religious affiliation buffered the relationship between community violence and substance abuse, for both African American and European emerging adults. In addition, more privately religious African American emerging adults engaged in less deviant behavior when exposed to higher levels of community violence. European Americans were not protected by private religiosity. PMID:20016764

3D Geological modelling - towards a European level infrastructure

NASA Astrophysics Data System (ADS)

Lee, Kathryn A.; van der Krogt, Rob; Busschers, Freek S.

2013-04-01

The joint European Geological Surveys are preparing the ground for a "European Geological Data Infrastructure" (EGDI), under the framework of the FP7-project EGDI-Scope. This scoping study, started in June 2012, for a pan-European e-Infrastructure is based on the successes of earlier joint projects including 'OneGeology-Europe' and aims to provide the backbone for serving interoperable, geological data currently held by European Geological Surveys. Also data from past, ongoing and future European projects will be incorporated. The scope will include an investigation of the functional and technical requirements for serving 3D geological models and will look to research the potential for providing a framework to integrate models at different scales, and form a structure for enabling the development of new and innovative model delivery mechanisms. The EGDI-scope project encourages pan-European inter-disciplinary collaboration between all European Geological Surveys. It aims to enhance emerging web based technologies that will facilitate the delivery of geological data to user communities involved in European policy making and international industry, but also to geoscientific research communities and the general public. Therefore, stakeholder input and communication is imperative to the success, as is the collaboration with all the Geological Surveys of Europe. The most important functional and technical requirements for delivery of such information at pan-European level will be derived from exchanges with relevant European stakeholder representatives and providers of geological data. For handling and delivering 3D geological model data the project will need to address a number of strategic issues: • Which are the most important issues and queries for the relevant stakeholders, requiring 3D geological models? How can this be translated to functional requirements for development and design of an integrated European application? • How to handle the very large

The Richer, the Happier? An Empirical Investigation in Selected European Countries

ERIC Educational Resources Information Center

Seghieri, Chiara; Desantis, Gustavo; Tanturri, Maria Letizia

2006-01-01

This study analyses the relationship between subjective and objective measures of well-being in selected European countries using the data of the European Community Household Panel (ECHP). In the first part of the paper, we develop a random-effect ordered probit model, separately for each country, relating the subjective measure of income…

A Grand Vision for European Astronomy

NASA Astrophysics Data System (ADS)

2007-09-01

Today, and for the first time, astronomers share their global Science Vision for European Astronomy in the next two decades. This two-year long effort by the ASTRONET network of funding agencies, sponsored by the European Commission and coordinated by INSU-CNRS, underscores Europe's ascension to world leadership in astronomy and its will to maintain that position. It will be followed in just over a year by a prioritised roadmap for the observational facilities needed to implement the Vision. Implementation of these plans will ensure that Europe fully contributes to Mankind's ever deeper understanding of the wonders of our Universe. astronet logo "This is a great opportunity to help create a vibrant long-term future for astronomy and science" says Tim de Zeeuw (Leiden Observatory, The Netherlands) who led this community-wide effort. The ASTRONET Science Vision provides a comprehensive overview of the most important scientific questions that European astronomy should address in the next twenty years. The four key questions are the extremes of the Universe, from the nature of the dark matter and dark energy that comprise over 95% of the Universe to the physics of extreme objects such as black holes, neutron stars, and gamma-ray bursts; the formation of galaxies from the first seeds to our Milky Way; the formation of stars and planets and the origin of life; and the crucial question of how do we (and our Solar System) fit in the global picture. These themes reach well beyond the realm of traditional astronomy into the frontiers of physics and biology. The Vision identifies the major new facilities that will be needed to achieve these goals, but also stresses the need for parallel developments in theory and numerical simulations, high-performance computing resources, efficient astronomical data archiving and the European Virtual Observatory, as well as in laboratory astrophysics. "This report is a key input for the even more challenging task of developing a prioritised

Effects of ethanol-based fuel contamination: microbial community changes, production of regulated compounds, and methane generation.

PubMed

Nelson, Denice K; Lapara, Timothy M; Novak, Paige J

2010-06-15

Ethanol-based fuels are becoming more heavily used, increasing the likelihood of ethanol-based fuel spills during transportation and storage. Although ethanol is well-known to be readily biodegradable, very little is known about the effects that such a spill might have on an indigenous microbial community. Of particular concern is that ethanol contamination could stimulate the growth of organisms that can generate regulated compounds and/or produce explosive quantities of methane gas. A column-based study was performed to elucidate the potential impacts of ethanol-based fuel (E85) on the indigenous microbial community during a simulated fuel spill. A continuous dilute supply of E85 resulted in profound shifts in both the bacterial and archaeal communities. The shift was accompanied by the production of high concentrations of volatile fatty acids and butanol, a compound that is regulated in groundwater by some states. Results also indicated that a continuous feed of dilute E85 generated explosive levels of methane within one month of column operation. Quantitative PCR data showed a statistically significant increase in methanogenic populations when compared to a control column. The elevated population numbers correlated to areas of the column receiving a sustained carbon load. Toxicity data indicated that microbial growth was completely inhibited (as evidenced by absence of ethanol breakdown products) at ethanol levels above 6% (v/v). These data suggest that ethanol from ethanol-based fuel can be readily degraded, but can also produce metabolic products that are regulated as well as explosive levels of methane. The core of an E85 spill may serve as a long-term source of contamination as it cannot be degraded until significant dilution has occurred.

[The development of European Union common research and development policy and programs with special regard to life sciences].

PubMed

Pörzse, Gábor

2009-08-09

Research and development (R&D) has been playing a leading role in the European Community's history since the very beginning of European integration. Its importance has grown in recent years, after the launch of the Lisbon strategy. Framework programs have always played a considerable part in community research. The aim of their introduction was to fine tune national R&D activities, and to successfully divide research tasks between the Community and the member states. The Community, from the very outset, has acknowledged the importance of life sciences. It is no coincidence that life sciences have become the second biggest priority in the last two framework programs. This study provides a historical, and at the same time analytical and evaluative review of community R&D policy and activity from the starting point of its development until the present day. It examines in detail how the changes in structure, conditional system, regulations and priorities of the framework programs have followed the formation of social and economic needs. The paper puts special emphasis on the analysis of the development of life science research, presenting how they have met the challenges of the age, and how they have been built into the framework programs. Another research area of the present study is to elaborate how successfully Hungarian researchers have been joining the community research, especially the framework programs in the field of life sciences. To answer these questions, it was essential to survey, process and analyze the data available in the national and European public and closed databases. Contrary to the previous documents, this analysis doesn't concentrate on the political and scientific background. It outlines which role community research has played in sustainable social and economic development and competitiveness, how it has supported common policies and how the processes of integration have been deepening. Besides, the present paper offers a complete review of

Progress in European CELSS activities

NASA Technical Reports Server (NTRS)

Skoog, A. I.

1987-01-01

The European Controlled Ecological Life Support System (CELSS) activities started in the late 1970's with system analysis and feasibility studies of Biological Life Support Systems (BLSS). The initiation for CELSS came from the industry side in Europe, but since then planning and hardware feasibility analyses have been initiated also from customer/agency side. Despite this, it is still too early to state that a CELSS program as a concerted effort has been agreed upon in Europe. However, the general CELSS objectives were accepted as planning and possible development goals for the European effort for manned space activities, and as experimental planning topics in the life sciences community for the next decades. It is expected that ecological life support systems can be tested and implemented on a space station towards the end of this century or early in the next. For the European activities a possible scenario can be projected based on ongoing life support system development activities and the present life sciences goals.

Regulation, consultation and divergent community views: the case of access to ART by lesbian and single women.

PubMed

Cannold, Leslie; Gillam, Lynn

2002-05-01

In the many countries which have some form of regulation of ART, a public consultation of some sort is a frequent feature of either the process leading up to regulation or of the regulatory mechanism itself. Not surprisingly, widely divergent views on the moral and political acceptability of ART are expressed during such consultations. And while such diversity of opinion is to be expected, and some even argue welcomed, in pluralist liberal democratic societies, it is often unclear how these divergent community views are and ought to be fed into the opinion-forming and decision-making processes of governments or the bodies that advise them. This article discusses first why regulation of ART may be justified, even when there is radical moral disagreement in the community, and why public consultations should play a central role in the work that advisory bodies undertake in making regulatory recommendations to government. Then, it both proposes and justifies a method for dealing with the contradictory moral views expressed by interested parties during the consultation process. To illustrate this method, the example of the attempt by single and lesbian women to access donor insemination services and ART is used.

The European Union Food Distribution programme for the Most Deprived Persons of the community, 1987-2013: From agricultural policy to social inclusion policy?

PubMed

Caraher, Martin

2015-07-01

The European Union Food Distribution programme for the Most Deprived Persons (MDP) of the community ran from 1987 until 2013. It was funded from Common Agricultural Policy budgets. The programme initially made use of surplus foods from the food mountains resulting from intervention stocks. This food was then distributed through aid agencies within member states, coordinated at a national government level. Reform of the CAP and global rises in food prices resulted in an increase in budget from €300 to €500 million Euros in 2010 with the added power to buy food on the open market. This led to a formal challenge to the scheme on the basis that buying goods on the open market shifted the emphasis from an agricultural/financial basis to a social one. A court ruling found that because the program was no longer used for removing surpluses the link to agriculture policy has become tenuous and therefore had no basis in community law. As a result of this legal challenge a number of policy compromises ensured the MDP would continue until the end of 2013 with a reduced budget. The scheme has been superseded by a new scheme in March 2014 called the Fund for European Aid to the Most Deprived (FEAD). This is seen as a social programme. The way that policy and politics developed and changed the MDP programme are set out. The article tracks its move from being an agricultural policy to a social welfare one. The key policy players and actors in this move are set out as are the changing context and policy frameworks. The replacement of the MDP by FEAD is discussed as is how intensive lobbying in 2012/13 resulted in the development of a new Fund for European Aid to the Most Deprived (FEAD). Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Global health in the European Union – a review from an agenda-setting perspective

PubMed Central

Aluttis, Christoph; Krafft, Thomas; Brand, Helmut

2014-01-01

This review attempts to analyse the global health agenda-setting process in the European Union (EU). We give an overview of the European perspective on global health, making reference to the developments that led to the EU acknowledging its role as a global health actor. The article thereby focusses in particular on the European interpretation of its role in global health from 2010, which was formalised through, respectively, a European Commission Communication and European Council Conclusions. Departing from there, and based on Kingdon's multiple streams theory on agenda setting, we identify some barriers that seem to hinder the further establishment and promotion of a solid global health agenda in the EU. The main barriers for creating a strong European global health agenda are the fragmentation of the policy community and the lack of a common definition for global health in Europe. Forwarding the agenda in Europe for global health requires more clarification of the common goals and perspectives of the policy community and the use of arising windows of opportunity. PMID:24560264

The impact of the treaty basis on health policy legislation in the European Union: A case study on the tobacco advertising directive

PubMed Central

Boessen, Sandra; Maarse, Hans

2008-01-01

Background The Europe Against Cancer programme was initiated in the late 1980s, recognising, among other risk factors, the problematic relationship between tobacco use and cancer. In an attempt to reduce the number of smokers in the European Community, the European Commission proposed a ban on tobacco advertising. The question of why it took over ten years of negotiating before the EU adopted a policy measure that could in fact improve the health situation in the Community, can only be answered by focusing on politics. Methods We used an actor-centred institutionalist approach, focusing on the strategic behaviour of the major actors involved. We concentrated our analysis on the legal basis as an important institution and evaluated how the absence of a proper legal basis for public health measures in the Treaties influenced policy-making, framing the discussion in market-making versus market-correcting policy interventions. For our analysis, we used primary and secondary sources, including policy documents, communications and press releases. We also conducted 9 semi-structured interviews. Results The ban on tobacco advertising was, in essence, a public health measure. The Commission used its agenda-setting power and framed the market-correcting proposal in market-making terms. The European Parliament and the Council of Ministers then used the discussion on the legal basis as a vehicle for real political controversies. After adoption of the ban on tobacco advertising, Germany appealed to the European Court of Justice, which annulled the ban but also offered suggestions for a possible solution with article 100a as the legal basis. Conclusion The whole market-making versus market-correcting discussion is related to a broader question, namely how far European health regulation can go in respect to the member states. In fact, the policy-making process of a tobacco advertising ban, as described in this paper, is related to the 'constitutional' foundation of health policy

The impact of the treaty basis on health policy legislation in the European Union: a case study on the tobacco advertising directive.

PubMed

Boessen, Sandra; Maarse, Hans

2008-04-08

The Europe Against Cancer programme was initiated in the late 1980s, recognising, among other risk factors, the problematic relationship between tobacco use and cancer. In an attempt to reduce the number of smokers in the European Community, the European Commission proposed a ban on tobacco advertising. The question of why it took over ten years of negotiating before the EU adopted a policy measure that could in fact improve the health situation in the Community, can only be answered by focusing on politics. We used an actor-centred institutionalist approach, focusing on the strategic behaviour of the major actors involved. We concentrated our analysis on the legal basis as an important institution and evaluated how the absence of a proper legal basis for public health measures in the Treaties influenced policy-making, framing the discussion in market-making versus market-correcting policy interventions. For our analysis, we used primary and secondary sources, including policy documents, communications and press releases. We also conducted 9 semi-structured interviews. The ban on tobacco advertising was, in essence, a public health measure. The Commission used its agenda-setting power and framed the market-correcting proposal in market-making terms. The European Parliament and the Council of Ministers then used the discussion on the legal basis as a vehicle for real political controversies. After adoption of the ban on tobacco advertising, Germany appealed to the European Court of Justice, which annulled the ban but also offered suggestions for a possible solution with article 100a as the legal basis. The whole market-making versus market-correcting discussion is related to a broader question, namely how far European health regulation can go in respect to the member states. In fact, the policy-making process of a tobacco advertising ban, as described in this paper, is related to the 'constitutional' foundation of health policy legislation in the Community. The

3-D bioprinting law regulation perspectives.

PubMed

Pashkov, Vitalii; Harkusha, Andrii

Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. General debate of last few years comes down to an attempt to resolve hesitation between legal attempts for regulation of 3-D biobrinting and concept of complete prohibition of such activities. An adequate response to the mentioned challenge is a reasonable position between some aspects of prohibition and self-regulation, resulting in a moderate number of regulations and standards for developing and marketing. Such regulations may concern an intellectual property (IP) rights, regulation of distribution, premarket restrictions, control mechanism etc. Scientific approach and regulatory settlement of 3-D bioprinting sphere must unite to achieve a fair balance between the interests of humanity and of individuals - on the one hand, and development of science and business benefits for stakeholders - on the other. The main instruments for this must be balanced regulation of intellectual property (IP) rights, regulation of access and distribution, premarket restrictions, control mechanism etc.

Higher prevalence of retinopathy in diabetic patients of South Asian ethnicity compared with white Europeans in the community: a cross-sectional study.

PubMed

Raymond, Neil T; Varadhan, Lakshminarayanan; Reynold, Dilini R; Bush, Kate; Sankaranarayanan, Sailesh; Bellary, Srikanth; Barnett, Anthony H; Kumar, Sudhesh; O'Hare, J Paul

2009-03-01

The purpose of this study was to compare prevalence and risk factors for diabetic retinopathy among U.K. residents of South Asian or white European ethnicity. This was a community-based cross-sectional study involving 10 general practices; 1,035 patients with type 2 diabetes were studied: 421 of South Asian and 614 of white European ethnicity. Diabetic retinopathy, sight-threatening retinopathy, maculopathy, and previous laser photocoagulation therapy were assessed after grading of retinal photographs. Data were collected on risk factors including age, duration, and treatment of diabetes, blood pressures, serum total cholesterol, and A1C. Patients of South Asian ethnicity had significantly higher systolic (144 vs. 137 mmHg, P < 0.0001) and diastolic (84 vs. 74 mmHg, P < 0.0001) blood pressure, A1C (7.9 vs. 7.5%, P < 0.0001), and total cholesterol (4.5 vs. 4.2 mmol/l, P < 0.0001). Diabetic retinopathy was detected in 414 (40%) patients (189 South Asian [45%] versus 225 white European [37%]; P = 0.0078). Sight-threatening retinopathy was detected in 142 (14%) patients (68 South Asian [16%] versus 74 white European [12%]; P = 0.0597). After adjustment for confounders, there were significantly elevated risks of any retinopathy and maculopathy for South Asian versus white European patients. Patients of South Asian ethnicity had a significantly higher prevalence of diabetic retinopathy and maculopathy, with significantly elevated systolic and diastolic blood pressure, A1C, and total cholesterol; lower attained age; and younger age at diagnosis. Earlier onset of disease and higher levels of modifiable risk factors make early detection of diabetes, annual referral for retinal screening, and intensive risk factor control key elements in addressing this health inequality.

Challenges of audit of care on clinical quality indicators for hypertension and type 2 diabetes across four European countries.

PubMed

Suija, Kadri; Kivisto, Katrin; Sarria-Santamera, Antonio; Kokko, Simo; Liseckiene, Ida; Bredehorst, Maren; Jaruseviciene, Lina; Papp, Renata; Oona, Marje; Kalda, Ruth

2015-02-01

The purpose of the study was to measure clinical quality by doing an audit of clinical records and to compare the performance based on clinical quality indicators (CQI) for hypertension and type 2 diabetes across seven European countries: Estonia, Finland, Germany, Hungary, Italy, Lithuania and Spain. Two common chronic conditions in primary care (PC), hypertension and type 2 diabetes, were selected for audit. The assessment of CQI started with a literature review of different databases: Organization for Economic Co-operation and Development, World Health Organization, European Commission European Community Health Indicators, US National Library of Medicine. Data were collected from clinical records. Although it was agreed to obtain the clinical indicators in a similar way from each country, the specific data collection process in every country varied greatly, due to different traditions in collecting and keeping the patients' data, as well as differences in regulation regarding access to clinical information. Also, there was a huge variability across countries in the level of compliance with the indicators. Measurement of clinical performance in PC by audit is methodologically challenging: different databases provide different information, indicators of quality of care have insufficient scientific proof and there are country-specific regulations. There are large differences not only in quality of health care across Europe but also in how it is measured. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Policy Maker's Anguish: Regulating Personal Data Behavior Between Paradoxes and Dilemmas

NASA Astrophysics Data System (ADS)

Compañó, Ramón; Lusoli, Wainer

Regulators in Europe and elsewhere are paying great attention to identity, privacy and trust in online and converging environments. Appropriate regulation of identity in a ubiquitous information environment is seen as one of the major drivers of the future Internet economy. Regulation of personal identity data has come to the fore including mapping conducted on digital personhood by the OECD; work on human rights and profiling by the Council of Europe andmajor studies by the European Commission with regard to self-regulation in the privacy market, electronic identity technical interoperability and enhanced safety for young people. These domains overlap onto an increasingly complex model of regulation of individuals' identity management, online and offline. This chapter argues that policy makers struggle to deal with issues concerning electronic identity, due to the apparently irrational and unpredictable behavior of users when engaging in online interactions involving identity management. Building on empirical survey evidence from four EU countries, we examine the first aspect in detail - citizens' management of identity in a digital environment. We build on data from a large scale (n = 5,265) online survey of attitudes to electronic identity among young Europeans (France, Germany, Spain, UK) conducted in August 2008. The survey asked questions about perceptions and acceptance of risks, general motivations, attitudes and behaviors concerning electronic identity. Four behavioral paradoxes are identified in the analysis: a privacy paradox (to date well known), but also a control paradox, a responsibility paradox and an awareness paradox. The chapter then examines the paradoxes in relation of three main policy dilemmas framing the debate on digital identity. The paper concludes by arguing for an expanded identity debate spanning policy circles and the engineering community.

7 CFR 3570.91 - Regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 15 2011-01-01 2011-01-01 false Regulations. 3570.91 Section 3570.91 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, DEPARTMENT OF AGRICULTURE COMMUNITY PROGRAMS Community Facilities Grant Program § 3570.91 Regulations. Grants under this part will be...

7 CFR 3570.91 - Regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Regulations. 3570.91 Section 3570.91 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, DEPARTMENT OF AGRICULTURE COMMUNITY PROGRAMS Community Facilities Grant Program § 3570.91 Regulations. Grants under this part will be...

International regulations on labour health and safety applied to fishing and maritime transport sectors. Are maritime workers under-protected.

PubMed

Rodríguez, Julio Louro; Portela, Rosa Mary de la Campa; Pardo, Guadalupe Martín

2012-01-01

The work activity developed on board is of great importance in our nearby environment, and it has a series of peculiarities that determine the service rendering of sea workers. On the other hand, work at sea is developed on an international basis. Nowadays such work becomes a completely globalised industrial sector in relation to the elements that make up the ship's operation, including manpower. For that reason several relevant international organisations have paid attention to this industrial sector and have adopted a broad regulation on this matter. In the case of the European Union, the Community procedure emphasises enormous interest in providing specific and comprehensive training to seafarers, as well as in regulating working time on board with the aim of minimising the safety problems caused by fatigue. In the present article a schematic presentation of regulations on workers' health and occupational safety protection derived from the European Union, the International Maritime Organisation, and the International Labour Organisation has been done. Also it shows what parts of these regulations are not applicable to the work on board, and it reveals how the workers of fishing and maritime transport sectors are under-protected with regard to the guarantee of their health and occupational safety compared to workers in other sectors.

Europe '92: Consequences of the European Unification for Cultural Federalism in the Federal Republic of Germany.

ERIC Educational Resources Information Center

Berggreen, Ingeborg

1990-01-01

Discusses consequences of European unification in the Federal Republic of Germany. Focuses on the relationships between the European Community, the federal government of Germany, and the German states. Suggests that the German states are aware of their responsibility to give education and culture a European dimension. (NL)

The future of European mining: What should our mining industry learn from the Skouries and Rosia Montana community gold conflicts

NASA Astrophysics Data System (ADS)

Hardy, Liam; Heller, Shaun; Faltyn, Rowan; Stefanaki, Anna; Economidou, Romina; Savin, Irina; Hood, Leo; Conway, Christopher

2017-04-01

The popular image of mining portrayed by media and by a majority of public opinion is a dominantly negative one. From worker's rights to environmental damages, disasters such as the Copiapó mine collapse (Chile), the acid mine drainage at Lousal (Portugal) and the Pb contamination of waters around the Tyndrum mines (Scotland) overshadow initiatives like the ICMM. Some companies receive little praise despite creating active community education and investment projects, while others simply build higher barbed wire fences and attempt to weather the protests, budgeting them into mine life assessments. This image problem, combined with the decentralised political segregation of Europe and the increased power of grass-roots protest initiatives (such as Antigold in Greece), has resulted in mining companies joining a long list of industries effected by the 'auto-protest' reaction in face of development, regardless of potential regional and national benefits, there is a pre-existing lack of trust in corporate and government powers to protect community interests. The poor management of existing licences is thus becoming a significant danger to future operations and the wider industry. Here we report on the Rosia Montana dispute (Romania) and the ongoing Skouries conflict (Greece). We then discuss how the European mining industry may need to significantly adapt its exploration and community engagement strategies to avoid future conflicts and, present a recent example of how effective suitably organised community engagement projects can be for local mining initiatives from Southern Portugal.

76 FR 52543 - European Larch Canker; Expansion of Regulated Areas

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

...-2011-0029, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118... Road Unit 26, Riverdale, MD 20737; (301) 734-0917. SUPPLEMENTARY INFORMATION: Background European larch... kill mature and immature species of the genus Larix (larch) and Pseudolarix (Golden larch). In parts of...

Aircraft LTO emissions regulations and implementations at European airports

NASA Astrophysics Data System (ADS)

Yunos, Siti Nur Mariani Mohd; Ghafir, Mohammad Fahmi Abdul; Wahab, Abas Ab

2017-04-01

Aviation affects the environment via the emission of pollutants from aircraft, impacting human health and ecosystem. Impacts of aircraft operations at lower ground towards local air quality have been recognized. Consequently, various standards and regulations have been introduced to address the related emissions. This paper discussed both environmental regulations by focusing more on the implementations of LTO emissions charges, an incentive-based regulation introduced in Europe as an effort to fill the gap in addressing the environmental issues related to aviation.

Parents' Reasons for Community Language Schools: Insight from a High-Shift, Non-Visible, Middle-Class Community

ERIC Educational Resources Information Center

Nordstrom, Janica

2016-01-01

In the past decade, there has been increased scholarly interest in the purpose and functions of community language schools, also known as heritage, supplementary or complementary schools. In particular, previous studies have focused on schools operating in minority communities deriving from Asian and Eastern-European countries, showing that…

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

PubMed Central

Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

2012-01-01

Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of

European grid services for global earth science

NASA Astrophysics Data System (ADS)

Brewer, S.; Sipos, G.

2012-04-01

This presentation will provide an overview of the distributed computing services that the European Grid Infrastructure (EGI) offers to the Earth Sciences community and also explain the processes whereby Earth Science users can engage with the infrastructure. One of the main overarching goals for EGI over the coming year is to diversify its user-base. EGI therefore - through the National Grid Initiatives (NGIs) that provide the bulk of resources that make up the infrastructure - offers a number of routes whereby users, either individually or as communities, can make use of its services. At one level there are two approaches to working with EGI: either users can make use of existing resources and contribute to their evolution and configuration; or alternatively they can work with EGI, and hence the NGIs, to incorporate their own resources into the infrastructure to take advantage of EGI's monitoring, networking and managing services. Adopting this approach does not imply a loss of ownership of the resources. Both of these approaches are entirely applicable to the Earth Sciences community. The former because researchers within this field have been involved with EGI (and previously EGEE) as a Heavy User Community and the latter because they have very specific needs, such as incorporating HPC services into their workflows, and these will require multi-skilled interventions to fully provide such services. In addition to the technical support services that EGI has been offering for the last year or so - the applications database, the training marketplace and the Virtual Organisation services - there now exists a dynamic short-term project framework that can be utilised to establish and operate services for Earth Science users. During this talk we will present a summary of various on-going projects that will be of interest to Earth Science users with the intention that suggestions for future projects will emerge from the subsequent discussions: • The Federated Cloud Task

EUROPLANET-RI modelling service for the planetary science community: European Modelling and Data Analysis Facility (EMDAF)

NASA Astrophysics Data System (ADS)

Khodachenko, Maxim; Miller, Steven; Stoeckler, Robert; Topf, Florian

2010-05-01

Computational modeling and observational data analysis are two major aspects of the modern scientific research. Both appear nowadays under extensive development and application. Many of the scientific goals of planetary space missions require robust models of planetary objects and environments as well as efficient data analysis algorithms, to predict conditions for mission planning and to interpret the experimental data. Europe has great strength in these areas, but it is insufficiently coordinated; individual groups, models, techniques and algorithms need to be coupled and integrated. Existing level of scientific cooperation and the technical capabilities for operative communication, allow considerable progress in the development of a distributed international Research Infrastructure (RI) which is based on the existing in Europe computational modelling and data analysis centers, providing the scientific community with dedicated services in the fields of their computational and data analysis expertise. These services will appear as a product of the collaborative communication and joint research efforts of the numerical and data analysis experts together with planetary scientists. The major goal of the EUROPLANET-RI / EMDAF is to make computational models and data analysis algorithms associated with particular national RIs and teams, as well as their outputs, more readily available to their potential user community and more tailored to scientific user requirements, without compromising front-line specialized research on model and data analysis algorithms development and software implementation. This objective will be met through four keys subdivisions/tasks of EMAF: 1) an Interactive Catalogue of Planetary Models; 2) a Distributed Planetary Modelling Laboratory; 3) a Distributed Data Analysis Laboratory, and 4) enabling Models and Routines for High Performance Computing Grids. Using the advantages of the coordinated operation and efficient communication between the

Network communities within and across borders.

PubMed

Cerina, Federica; Chessa, Alessandro; Pammolli, Fabio; Riccaboni, Massimo

2014-04-01

We investigate the impact of borders on the topology of spatially embedded networks. Indeed territorial subdivisions and geographical borders significantly hamper the geographical span of networks thus playing a key role in the formation of network communities. This is especially important in scientific and technological policy-making, highlighting the interplay between pressure for the internationalization to lead towards a global innovation system and the administrative borders imposed by the national and regional institutions. In this study we introduce an outreach index to quantify the impact of borders on the community structure and apply it to the case of the European and US patent co-inventors networks. We find that (a) the US connectivity decays as a power of distance, whereas we observe a faster exponential decay for Europe; (b) European network communities essentially correspond to nations and contiguous regions while US communities span multiple states across the whole country without any characteristic geographic scale. We confirm our findings by means of a set of simulations aimed at exploring the relationship between different patterns of cross-border community structures and the outreach index.

European activities in radiation protection in medicine.

PubMed

Simeonov, Georgi

2015-07-01

The recently published Council Directive 2013/59/Euratom ('new European Basic Safety Standards', EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom 'BSS' and the 97/43/Euratom 'Medical Exposure' Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe-these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (non-medical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions

Fostering Self-Regulated Learning through the European Language Portfolio: An Embedded Mixed Methods Study

ERIC Educational Resources Information Center

Ziegler, Nicholas Allan

2014-01-01

The European Language Portfolio (ELP) is an alternative assessment used in foreign language classes throughout Europe to support and record language learning. Directly linked to the Common European Framework of Reference for Languages (Council of Europe, 2001) proficiency guidelines, it is designed to achieve an ambitious dual goal: document…

Formative Self-Assessment College Classes Improves Self-Regulation and Retention in First/Second Year Community College Students

ERIC Educational Resources Information Center

Mahlberg, Jamie

2015-01-01

This research examined the influence formative self-assessment had on first/second year community college student self-regulatory practices. Previous research has shown that the ability to regulate one's learning activities can improve performance in college classes, and it has long been known that the use of formative assessment improves…

ENVRIplus - European collaborative development of environmental infrastructures

NASA Astrophysics Data System (ADS)

Asmi, A.; Brus, M.; Kutsch, W. L.; Laj, P.

2016-12-01

European Research Infrastructures (RI) are built using ESFRI process, which dictates the steps towards a common European RIs. Building each RI separately creates unnessary barriers towards service users (e.g. on differing standards) and is not effiicient in e.g. e-science tool or data system development. To answer these inter-RI issues, the European Commission has funded several large scale cluster projectsto bring these RIs together already in planning and development phases to develop common tools, standards and methodologies, as well as learn from the exisiting systems. ENVRIplus is the cluster project for the environmental RIs in Europe, and provides platform for common development and sharing within the RI community. The project is organized around different themes, each having several workpackages with specific tasks. Major themesof the ENVRIplus are: Technical innovation, including tasks such as RI technology transfer, new observation techniques, autonomous operation, etc.; Data for science, with tasks such as RI reference model development, data discovery and citation, data publication, processing, etc.; Access to RIs, with specific tasks on interdicplinary and transnational access to RI services, and common access governance; Societal relevance and understanding, tackling on ethical issues on RI operations and understanding on human-environmental system and citizen science approaches, among others; Knowledge transfer, particularly between the RIs, and with developing RI organizations, organizing training and staff exchange; and Communication and dissemination, working towards a common environmental RI community (ENVRI community platform), and creating an own advisory RI discussion board (BEERi), and disseminating the ENVRIplus products globally. Importantly, all ENVRIplus results are open to any users from any country. Also, collaboration with international RIs and user communities are crucial to the success of the ENVRI initiatives. Overall goal is to do

Standardizing the European Education Policy Space

ERIC Educational Resources Information Center

Lawn, Martin

2011-01-01

Countries in Europe, through the European Union, are creating, as part of the market and its governance, a new policy space in education. It is being formed through law, regulation, networking and harmonization. The development of standards across the different fields of policy, statistical calculation and commerce underpins and extends the…

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.

PubMed

Mosconi, Paola; Antes, Gerd; Barbareschi, Giorgio; Burls, Amanda; Demotes-Mainard, Jacques; Chalmers, Iain; Colombo, Cinzia; Garattini, Silvio; Gluud, Christian; Gyte, Gill; Mcllwain, Catherine; Penfold, Matt; Post, Nils; Satolli, Roberto; Valetto, Maria Rosa; West, Brian; Wolff, Stephanie

2016-01-12

The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence. The principal communication materials developed were: 1. A website ( http://ecranproject.eu ) in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN project 2. An animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorial 3. An inventory of resources, available in 23 languages, searchable by topic, author, and media type 4. Two educational games for young people, developed in six languages 5. Testing Treatments interactive in a dozen languages, including five official European Community languages 6. An interactive tutorial slide presentation testing viewers' knowledge about clinical trials Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network.

Globalization of environmental regulations for offshore E & P operations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shannon, B.E.

1995-12-31

One of the enduring legacies of the Rio Environmental Summit of 1992 (United Nations Conference on Environment and Development, UNCED) is Agenda 21 (Chapter 17 - Protection of the Oceans), which among other things called for the assessment of the need for a global authority to regulate offshore Exploration & Production (E&P) discharges, emissions and safety. Despite advice to the contrary from the International Maritime Organization (IMO), interest is building within the European community for the standardization of regulations for offshore E&P activities. Several international of regulations for offshore E&P activities. Several international frameworks or forums have been mentioned asmore » possible candidates. These include the United Nations Convention on the Law of the Sea, 1982 (UNCLOS); London Convention 1972 (LC 1972) and the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 (MARPOL) 73/78. International offshore oil and gas operators operate within requirements of regional conventions under the United Nations Environmental Program`s (UNEP) - Regional Seas Program. Domestic offshore operations are undertaken under the auspices of the U.S. Environmental Protection Agency and Minerals Management Service.« less

Why Do Adults Learn? Developing a Motivational Typology across 12 European Countries

ERIC Educational Resources Information Center

Boeren, Ellen; Holford, John; Nicaise, Ides; Baert, Herman

2012-01-01

Participation in adult education is today generally considered an individual responsibility. However, participation is the result of a complex bounded agency between individuals, educational institutions and regulating governments. This paper explores the motives of 12,000 European adult learners in formal adult education in 12 European countries.…

Perceptions of dementia and use of services in minority ethnic communities: a scoping exercise.

PubMed

Parveen, Sahdia; Peltier, Carol; Oyebode, Jan R

2017-03-01

Despite the rapidly ageing population and a predicted sevenfold increase in the prevalence of dementia in minority ethnic communities, people from these communities remain under-represented in specialist dementia services. Leventhal's Model of Self-Regulation suggests perceptions of illness facilitate help-seeking behaviours such as the use of services. This scoping exercise makes use of the model to explore perceptions of dementia in British Indian, African and Caribbean, and East and Central European communities in the United Kingdom. Between August 2013 and April 2014, culturally specific dementia awareness roadshows were attended by people living with dementia, carers and members of the public. During the roadshows, 62 British Indian, 50 African and Caribbean, and 63 East and Central European attenders participated in discussion groups and a dementia knowledge quiz. Thematic and framework analysis were conducted on the discussion group data. Three main themes are presented: Perceptions of dementia, awareness of dementia in the wider family and community, and awareness and use of services. The findings suggest that although groups attributed a biological basis for memory loss, a number of misconceptions prevailed regarding the cause of dementia. Groups also made use of religion, as opposed to medical healthcare services, as a form of personal and treatment control. Seeking help from healthcare services was hindered by lack of awareness of services, and culturally specific barriers such as language. The findings have a number of implications for policy and practice including the development of public health interventions and the need to focus further on reducing barriers to accessing services. © 2016 John Wiley & Sons Ltd.

Top-down regulation, climate and multi-decadal changes in coastal zoobenthos communities in two Baltic Sea areas.

PubMed

Olsson, Jens; Bergström, Lena; Gårdmark, Anna

2013-01-01

The structure of many marine ecosystems has changed substantially during recent decades, as a result of overexploitation, climate change and eutrophication. Despite of the apparent ecological and economical importance of coastal areas and communities, this aspect has received relatively little attention in coastal systems. Here we assess the temporal development of zoobenthos communities in two areas on the Swedish Baltic Sea coast during 30 years, and relate their development to changes in climate, eutrophication and top-down regulation from fish. Both communities show substantial structural changes, with a decrease in marine polychaetes and species sensitive to increased water temperatures. Concurrently, opportunistic species tolerant to environmental perturbation have increased in abundance. Species composition show a similar temporal development in both communities and significant changes in species composition occurred in both data sets in the late 1980s and early 1990s. The change in species composition was associated with large scale changes in climate (salinity and water temperature) and to the structure of the local fish community, whereas we found no effects of nutrient loading or ambient nutrient concentrations. Our results suggest that these coastal zoobenthos communities have gone through substantial structural changes over the last 30 years, resulting in communities of different species composition with potentially different ecological functions. We hence suggest that the temporal development of coastal zoobenthos communities should be assessed in light of prevailing climatic conditions considering the potential for top-down effects exerted by local fish communities.

Top-Down Regulation, Climate and Multi-Decadal Changes in Coastal Zoobenthos Communities in Two Baltic Sea Areas

PubMed Central

Olsson, Jens; Bergström, Lena; Gårdmark, Anna

2013-01-01

The structure of many marine ecosystems has changed substantially during recent decades, as a result of overexploitation, climate change and eutrophication. Despite of the apparent ecological and economical importance of coastal areas and communities, this aspect has received relatively little attention in coastal systems. Here we assess the temporal development of zoobenthos communities in two areas on the Swedish Baltic Sea coast during 30 years, and relate their development to changes in climate, eutrophication and top-down regulation from fish. Both communities show substantial structural changes, with a decrease in marine polychaetes and species sensitive to increased water temperatures. Concurrently, opportunistic species tolerant to environmental perturbation have increased in abundance. Species composition show a similar temporal development in both communities and significant changes in species composition occurred in both data sets in the late 1980s and early 1990s. The change in species composition was associated with large scale changes in climate (salinity and water temperature) and to the structure of the local fish community, whereas we found no effects of nutrient loading or ambient nutrient concentrations. Our results suggest that these coastal zoobenthos communities have gone through substantial structural changes over the last 30 years, resulting in communities of different species composition with potentially different ecological functions. We hence suggest that the temporal development of coastal zoobenthos communities should be assessed in light of prevailing climatic conditions considering the potential for top-down effects exerted by local fish communities. PMID:23737998

New Challenges in the Education and Training of the European Workforce. Final Report. A Seminar for EC and EFTA Countries on Policies for Education and Training of the Labour Force in a Changing European Economy (Stockholm, Sweden, June 13-14, 1990).

ERIC Educational Resources Information Center

National Swedish Board of Education, Stockholm.

This report provides presentations from a seminar attended by delegates from all the European Community and European Free Trade Association (EFTA) countries to discuss policy planning for education and training. "The European Skill Gap--Introductory Comments" (Abrahamsson, Henriksson) provides an overview of the seminar and topics…

European Union policy on pesticides: implications for agriculture in Ireland.

PubMed

Jess, Stephen; Kildea, Steven; Moody, Aidan; Rennick, Gordon; Murchie, Archie K; Cooke, Louise R

2014-11-01

European Community (EC) legislation has limited the availability of pesticide active substances used in effective plant protection products. The Pesticide Authorisation Directive 91/414/EEC introduced the principle of risk assessment for approval of pesticide active substances. This principle was modified by the introduction of Regulation (EC) 1107/2009, which applies hazard, the intrinsic toxicity of the active substance, rather than risk, the potential for hazard to occur, as the approval criterion. Potential impacts of EC pesticide legislation on agriculture in Ireland are summarised. While these will significantly impact on pesticide availability in the medium to long term, regulations associated with water quality (Water Framework Directive 2000/60/EC and Drinking Water Directive 1998/83/EC) have the potential to restrict pesticide use more immediately, as concerns regarding public health and economic costs associated with removing pesticides from water increase. This rationale will further reduce the availability of effective pesticide active substances, directly affecting crop protection and increasing pesticide resistance within pest and disease populations. In addition, water quality requirements may also impact on important active substances used in plant protection in Ireland. The future challenge for agriculture in Ireland is to sustain production and profitability using reduced pesticide inputs within a framework of integrated pest management. © 2014 Society of Chemical Industry.

Education and Communities at the "Margins": The Contradictions of Western Education for Islamic Communities in Sub-Saharan Africa

ERIC Educational Resources Information Center

Mfum-Mensah, Obed

2017-01-01

This paper employs postcolonial framework to discuss the contradictions of promoting western education in Islamic communities in sub-Saharan Africa (SSA). Prior to colonization, Islamic education was an important socializing process that instilled strong Islamic identity in Islamic communities in SSA. European encounters in SSA and the…

The Effects of Self-Regulated Learning Training on Community College Students' Metacognition and Achievement in Developmental Math Courses

ERIC Educational Resources Information Center

Bol, Linda; Campbell, Karen D. Y.; Perez, Tony; Yen, Cherng-Jyh

2016-01-01

The effects of training in self-regulation on metacognition and math achievement were investigated. The participants were 116 community college students enrolled in developmental math courses. Students enrolled in 16 classrooms were randomly assigned to the treatment and control groups. Participants in the treatment group completed four…

Vocational Training and European Standardisation of Qualifications: The Case of Aircraft Maintenance

ERIC Educational Resources Information Center

Haas, Joachim; Ourtau, Maurice

2009-01-01

Initiatives to standardise the conditions for practising certain regulated activities are being taken at European level, particularly in light of the free movement of people and the recognition of qualifications in Member states. This paper looks at the introduction of european licences for aircraft maintenance engineers. It follows an in-depth…

Regulating chemicals: law, science, and the unbearable burdens of regulation.

PubMed

Silbergeld, Ellen K; Mandrioli, Daniele; Cranor, Carl F

2015-03-18

The challenges of regulating industrial chemicals remain unresolved in the United States. The Toxic Substances Control Act (TSCA) of 1976 was the first legislation to extend coverage to the regulation of industrial chemicals, both existing and newly registered. However, decisions related to both law and science that were made in passing this law inevitably rendered it ineffectual. Attempts to fix these shortcomings have not been successful. In light of the European Union's passage of innovative principles and requirements for chemical regulation, it is no longer possible to deny the opportunity and need for reform in US law and practice.

Network communities within and across borders

PubMed Central

Cerina, Federica; Chessa, Alessandro; Pammolli, Fabio; Riccaboni, Massimo

2014-01-01

We investigate the impact of borders on the topology of spatially embedded networks. Indeed territorial subdivisions and geographical borders significantly hamper the geographical span of networks thus playing a key role in the formation of network communities. This is especially important in scientific and technological policy-making, highlighting the interplay between pressure for the internationalization to lead towards a global innovation system and the administrative borders imposed by the national and regional institutions. In this study we introduce an outreach index to quantify the impact of borders on the community structure and apply it to the case of the European and US patent co-inventors networks. We find that (a) the US connectivity decays as a power of distance, whereas we observe a faster exponential decay for Europe; (b) European network communities essentially correspond to nations and contiguous regions while US communities span multiple states across the whole country without any characteristic geographic scale. We confirm our findings by means of a set of simulations aimed at exploring the relationship between different patterns of cross-border community structures and the outreach index. PMID:24686380

Medical research in emergency research in the European Union member states: tensions between theory and practice.

PubMed

Kompanje, Erwin J O; Maas, Andrew I R; Menon, David K; Kesecioglu, Jozef

2014-04-01

In almost all of the European Union member states, prior consent by a legal representative is used as a substitute for informed patient consent for non-urgent medical research. Deferred (patient and/or proxy) consent is accepted as a substitute in acute emergency research in approximately half of the member states. In 12 European Union member states emergency research is not mentioned in national law. Medical research in the European Union is covered by the Clinical Trial Directive 2001/20/EC. A proposal for a regulation by the European Commission is currently being examined by the European Parliament and the Council and will replace Directive 2001/20/EC. Deferred patient and/or proxy consent is allowed in the proposed regulation, but does not fit completely in the practice of emergency research. For example, deferred consent is only possible when legal representatives are not available. This criterion will delay inclusion of patients in acute life-threatening conditions in short time frames. As the regulation shall be binding in its entirety in all member states, emergency research in acute situations is still not possible as it should be.

European perspectives on pediatric formulations.

PubMed

Breitkreutz, Jörg

2008-11-01

The 2007 European Union (EU) regulation on medicinal products for pediatric use may change the present unsatisfying situation in the EU by stimulating research and development of medicines for use in children through rewards and incentives. This commentary reflects on the new EU regulations and guidelines, with special attention paid to the impact on pediatric formulation science. The focus of this article is on the EU perspective for pediatric formulations and highlights the differences compared with the pediatric drug formulation situation in the United States. Materials for this article were gathered during a literature search of MEDLINE and Chemical Abstracts (1970-October 2008) using the following terms: paediatric/pediatric drug formulations, age-appropriate dosage forms, child-appropriate medicines, and paediatric/pediatric regulation. Since the EU legislation on medicines for children came into force in 2007, a great emphasis has been placed on creating new organizations, scientific networks, and programs dealing with pediatric medicines and child-appropriate drug formulations. Although the US legislation was an appropriate model, the EU introduced some novel measures to improve the current situation, such as the Paediatric Investigation Plan and the Paediatric Use Marketing Authorisation. For globally operating pharmaceutical companies, the peculiarities of the European market have a strong impact on their product development strategies. Because the European approach demands early investigations into drug formulations for children, various issues must be resolved, including the following: choosing formulations for each age group, determining which excipients may be used in the formulation and which delivery device is appropriate, and predicting the taste sensation of an oral formulation. Numerous initiatives and networks are evolving in Europe. An important future task will be the coordination of these activities and the linking to other groups working on

Cosmetic Regulations: A Comparative Study.

PubMed

Suhag, Jyoti; Dureja, Harish

2015-01-01

The regulatory framework, compliance requirement, efficacy, safety, and marketing of cosmetic products are considered the most important factors for growth of the cosmetic industry. There are different regulatory bodies across the globe that have their own insights for regulation; moreover, governments such as the United States, European Union, and Japan follow a stringent regulatory framework, whereas cosmetics are not so much strictly regulated in countries such as India, Brazil, and China. The alignment of a regulatory framework will play a significant role in the removal of barriers to trade, growth of market at an international level, innovation in the development and presentation of new products, and most importantly safety and efficacy of the marketed products. The present contribution gives insight into the important cosmetic regulations in areas of premarket approval, ingredient control, and labeling and warnings, with a special focus on the cosmetic regulatory environments in the United States, European Union, Japan, and India. Most importantly, the authors highlight the dark side of cosmetics associated with allergic reactions and even skin cancer. The importance of cosmetic regulations has been highlighted by dint of which the society can be healthier, accomplished by more stringent and harmonized regulations.

European research efforts in medical knowledge-based systems.

PubMed

Stefanelli, M

1993-04-01

This article describes the major projects going on in Europe in the field of Artificial Intelligence in Medicine. The important role of the Commission of the European Communities in providing the needed resources is stressed throughout the paper. Particular attention is given to the methodological and technological issues addressed by the European research teams, since the results which these teams accomplish are fundamental for a more extensive diffusion of knowledge-based systems in real medical settings. The variety of medical problems tackled shows that there is no field of medicine where the potential of advanced informatics technologies has not yet been assessed.

Oocyte donation for reproduction and research cloning--the perils of commodification and the need for European and international regulation.

PubMed

Schneider, Ingrid

2006-01-01

The demand for women's egg cells is increasing and is leading to reproductive tourism and transnational oocyte trafficking. The article considers the regulatory landscape of oocyte donation in Europe and analyses different types, particularly whether oocytes are provided within or outside of the IVF context, and whether anonymity of the donor is legally possible or not. The bifurcation between different purposes of egg extraction, particularly the challenges raised by ova demands for cloning research (SCNT) are highlighted. In emphasizing the need for supranational regulation, nine rules for supranational minimum standards are proposed to protect both donor interests and the public good. A particular focus is directed to the commodification of oocytes with regard to the European principle of non-commercial, voluntary and altruistic donation.

UK medicines regulation: responding to current challenges

PubMed Central

Richards, Natalie

2016-01-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk‐proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. PMID:27580254

Life cycle environmental evaluation of kettles: Recommendations for the development of eco-design regulations in the European Union.

PubMed

Gallego-Schmid, Alejandro; Jeswani, Harish Kumar; Mendoza, Joan Manuel F; Azapagic, Adisa

2018-06-01

Between 117 and 200 million kettles are used in the European Union (EU) every year. However, the full environmental impacts of kettles remain largely unknown. This paper presents a comprehensive life cycle assessment of conventional plastic and metallic kettles in comparison with eco-kettles. The results show that the use stage contributes 80% to the impacts. For this reason, the eco-kettle has over 30% lower environmental impacts due to a greater water efficiency and related lower energy consumption. These results have been extrapolated to the EU level to consider the implications for proposed eco-design regulations. For these purposes, the effects on the impacts of durability of kettles and improvements in their energy and water efficiency have been assessed as they have been identified as two key parameters in the proposed regulations. The results suggest that increasing the current average durability from 4.4 to seven years would reduce the impacts by less than 5%. Thus, improving durability is not a key issue for improving the environmental performance of kettles and does not justify the need for an eco-design regulation based exclusively on it. However, improvements in water and energy efficiency through eco-design can bring relevant environmental savings. Boiling the exact amount of water needed would reduce the impacts by around a third and using water temperature control by further 2%-5%. The study has also considered the effects of reducing significantly the number of kettles in use after the UK (large user of kettles) leaves the EU and reducing the excess water typically boiled by the consumer. Even under these circumstances, the environmental savings justify the development of a specific EU eco-design regulation for kettles. However, consumer engagement will be key to the implementation and achievement of the expected environmental benefits. Copyright © 2017 Elsevier B.V. All rights reserved.

Initial and Continuing Vocational Training in Europe. European Report. CEDEFOP Panorama. First Edition.

ERIC Educational Resources Information Center

Piehl, Ernst; Sellin, Burkart

In accordance with the Treaty on European Union, the European Community (EC) has a supportive role to play for the Member States in the areas of education and vocational training. The free movement of persons, the right to establish a business, and the freedom to provide services are among the most important fundamental rights which apply…

[Policies encouraging price competition in the generic drug market: Lessons from the European experience].

PubMed

Puig-Junoy, Jaume

2010-01-01

To describe alternative policies aimed at encouraging price competition in generic drug markets in countries with strict price regulation, and to present some case studies drawn from the European experience. Systematic literature review of articles and technical reports published after 1999. The shortcomings in consumer price competition observed in some European generic markets, including Spain, may be reduced through three types of public reimbursement or financing reforms: policies aimed at improving the design of current maximum reimbursement level policies; policies aimed at monitoring competitive prices in order to reimburse real acquisition cost to pharmacies; and, more radical and market-oriented policies such as competitive tendering of public drug purchases. The experience of recent reforms adopted in Germany, Belgium, Holland, Norway, and Sweden offers a useful guide for highly price-regulated European countries, such as Spain, currently characterized by limited consumer price competition and the high discounts offered to pharmacy purchases. Direct price regulation and/or the generic reference pricing systems used to reduce generic drug prices in many European countries can be successfully reformed by adopting measures more closely aimed at encouraging consumer price competition in generic drug markets. Copyright 2009 SESPAS. Published by Elsevier Espana. All rights reserved.

Localism in Western European Radio Broadcasting: Untangling the Wireless.

ERIC Educational Resources Information Center

McCain, Thomas A.; Lowe, G. Ferrell

1990-01-01

Provides an overview of the local radio phenomenon in Western European countries. Examines opportunities for access, control, and economic realities for three types of local radio (national, independent, and community), each of which was influenced in some fashion by illegal pirate stations. (KEH)

Regulating danger on the highways: hours of service regulations.

PubMed

Mansfield, Daniel; Kryger, Meir

2015-12-01

Current hours of service regulations governing commercial truck drivers in place in the United States, Canada, Australia, and the European Union are summarized and compared to facilitate the assessment of the effectiveness of such provisions in preventing fatigue and drowsiness among truck drivers. Current hours of service provisions governing commercial truck drivers were derived from governmental sources. The commercial truck driver hours of service provisions in the United States, Canada, and the European Union permit drivers to work 14 hours and those of Australia permit drivers to work 12 hours a day on a regular basis. The regulations do not state what a driver may do with time off. They are consistent with a driver being able to drive after 24 hours without sleep. They do not take into account circadian rhythm by linking driving or rest to time of day. Current hours of service regulations governing commercial truck drivers leave gaps--permitting drivers to work long hours on a regular basis, permitting driving after no sleep for 24 hours, and failing to take into account the importance of circadian rhythm, endangering the public safety and the truck drivers themselves. Copyright © 2015 National Sleep Foundation. Published by Elsevier Inc. All rights reserved.

Current european regulatory perspectives on insulin analogues.

PubMed

Enzmann, Harald G; Weise, Martina

2011-07-07

Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs) are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.

The effect of social relationships on survival in elderly residents of a Southern European community: a cohort study

PubMed Central

Rodriguez-Laso, Angel; Zunzunegui, Maria Victoria; Otero, Angel

2007-01-01

Background Comparative evidence regarding the effects of social relationships on mortality in Mediterranean communities will increase our knowledge of their strengths and the ways in which they influence longevity across cultures. Men and women may benefit differently from social relationships because of cultural differences in gender roles. Psychosocial mechanisms such as social support, which may explain the effects of social networks, may also vary by culture. Methods Detailed information on the social relationships of a representative sample of 1,174 community-dwelling older adults was collected in Leganés, a city in central Spain. Mortality over a 6-year follow-up period was ascertained. Information on socio-demographic, health and disability variables was also collected. Cox proportional hazards models were fitted separately for men and women and for the combined sample. Results Having a confidant was associated with a 25% (95% CI 5–40%) reduction in the mortality risk. The hazard ratio for lack of social participation was 1.5 (95% CI 1.3–1.7). Being engaged in meaningful roles protected against mortality, while receipt of emotional support did not affect survival. These results were comparable for men and women. Having contact with all family ties was associated with reduced mortality only in men. Structural aspects of social networks make a unique contribution to survival, independently of emotional support and the role played in the lives of significant others. Conclusion In this elderly Southern European population, the beneficial effects of social networks, social participation, engagement in the life of significant others and having a confidant call for public policies that foster intergenerational and community exchanges. PMID:17678536

Mobbing in Bosnia and Herzegovina and the member states of the European Union

NASA Astrophysics Data System (ADS)

Rodic, V.

2016-08-01

Mobbing as a specific form of discrimination which applies only to the labor law, is a very young branch of labor law. It began to develop during the eighties of last century. This kind of psychoterror that appears in the workplace, was first spotted, formulated and diagnosed by the Swedish psychologist of German origin prof. Dr. Heinz Lejman (Heinz Leymann July 17, 1932.; Wolfenbuttel, Germany - 1999 Stockholm, Sweden). Today, the legal regulation of mobbing in terms of prevention, rules of behavior and sanctions is indispensable to every modern democratic state. I'll make a comparison of the legislative regulation provided by BiH with several European Union member states. I will compare the results of a survey conducted by the European Foundation for the Improvement of Living and Working Condition, during the year 2000. In the European Union Member States, with the results of the questionnaire for employees, which I conducted in Bosnia and Herzegovina. The conclusion I came to in this paper is: Bosnia and Herzegovina is lagging behind a lot of European Union member states, both in terms of prevention of mobbing, as well as legislation, that is insufficient to regulate this complex issue. Results of the questionnaire for the employees that I conducted in Bosnia and Herzegovina are devastating and alarming.

Strategies for public health research in European Union countries.

PubMed

Grimaud, Olivier; McCarthy, Mark; Conceição, Claudia

2013-11-01

'Health' is an identifiable theme within the European Union multi-annual research programmes. Public Health Innovation and Research in Europe (PHIRE), led by the European Public Health Association, sought to identify public health research strategies in EU member states. Within PHIRE, national public health associations reviewed structures for health research, held stakeholder workshops and produced reports. This information, supplemented by further web searches, including using assisted translation, was analysed for national research strategies and health research strategies. All countries described general research strategies, outlining organizational and capacity objectives. Thematic fields, including health, are mentioned in some strategies. A health research strategy was identified for 15 EU countries and not for 12. Ministries of health led research strategies for nine countries. Public health research was identified in only three strategies. National research strategies did not refer to the European Union's health research programme. Public health research strategies of European countries need to be developed by ministries of health, working with the research community to achieve the European Research Area.

Ancient DNA Analysis Reveals High Frequency of European Lactase Persistence Allele (T-13910) in Medieval Central Europe

PubMed Central

Akgül, Gülfirde; Della Casa, Philippe; Rühli, Frank; Warinner, Christina

2014-01-01

Ruminant milk and dairy products are important food resources in many European, African, and Middle Eastern societies. These regions are also associated with derived genetic variants for lactase persistence. In mammals, lactase, the enzyme that hydrolyzes the milk sugar lactose, is normally down-regulated after weaning, but at least five human populations around the world have independently evolved mutations regulating the expression of the lactase-phlorizin-hydrolase gene. These mutations result in a dominant lactase persistence phenotype and continued lactase tolerance in adulthood. A single nucleotide polymorphism (SNP) at C/T-13910 is responsible for most lactase persistence in European populations, but when and where the T-13910 polymorphism originated and the evolutionary processes by which it rose to high frequency in Europe have been the subject of strong debate. A history of dairying is presumed to be a prerequisite, but archaeological evidence is lacking. In this study, DNA was extracted from the dentine of 36 individuals excavated at a medieval cemetery in Dalheim, Germany. Eighteen individuals were successfully genotyped for the C/T-13910 SNP by molecular cloning and sequencing, of which 13 (72%) exhibited a European lactase persistence genotype: 44% CT, 28% TT. Previous ancient DNA-based studies found that lactase persistence genotypes fall below detection levels in most regions of Neolithic Europe. Our research shows that by AD 1200, lactase persistence frequency had risen to over 70% in this community in western Central Europe. Given that lactase persistence genotype frequency in present-day Germany and Austria is estimated at 71–80%, our results suggest that genetic lactase persistence likely reached modern levels before the historic population declines associated with the Black Death, thus excluding plague-associated evolutionary forces in the rise of lactase persistence in this region. This new evidence sheds light on the dynamic evolutionary

Impact of regulation of Community Pharmacies on efficiency, access and equity. Evidence from the UK and Spain.

PubMed

Lluch, Maria; Kanavos, Panos

2010-05-01

In this paper, we focus on regulatory restrictions on Community Pharmacies and whether these have an impact on efficiency, access and equity and thus in the delivery of services community pharmacists provide to patients. Primary data collection through semi-structured interviews and secondary data collection through literature review have been used with a particular focus on Spain (a country where Community Pharmacy is strictly regulated) and the UK (a country where Community Pharmacy is considered liberalised by EU standards). The findings indicate that improved pharmacy operational efficiency is the result of appropriate incentive structures, ownership liberalisation and OTC price freedom as is the case in the UK. Equity and access seem to be better achieved by establishing geographic, demographic or needs-based criteria to open new pharmacies (as is the case in Spain). In sum, there are useful lessons for both countries: the UK could look into the policies applied in Spain that increase access and equity whilst Spain could adopt some of the policies from the UK to increase efficiency in the system. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

Drosophila Regulate Yeast Density and Increase Yeast Community Similarity in a Natural Substrate

PubMed Central

Stamps, Judy A.; Yang, Louie H.; Morales, Vanessa M.; Boundy-Mills, Kyria L.

2012-01-01

Drosophila melanogaster adults and larvae, but especially larvae, had profound effects on the densities and community structure of yeasts that developed in banana fruits. Pieces of fruit exposed to adult female flies previously fed fly-conditioned bananas developed higher yeast densities than pieces of the same fruits that were not exposed to flies, supporting previous suggestions that adult Drosophila vector yeasts to new substrates. However, larvae alone had dramatic effects on yeast density and species composition. When yeast densities were compared in pieces of the same fruits assigned to different treatments, fruits that developed low yeast densities in the absence of flies developed significantly higher yeast densities when exposed to larvae. Across all of the fruits, larvae regulated yeast densities within narrow limits, as compared to a much wider range of yeast densities that developed in pieces of the same fruits not exposed to flies. Larvae also affected yeast species composition, dramatically reducing species diversity across fruits, reducing variation in yeast communities from one fruit to the next (beta diversity), and encouraging the consistent development of a yeast community composed of three species of yeast (Candida californica, C. zemplinina, and Pichia kluvyeri), all of which were palatable to larvae. Larvae excreted viable cells of these three yeast species in their fecal pools, and discouraged the growth of filamentous fungi, processes which may have contributed to their effects on the yeast communities in banana fruits. These and other findings suggest that D. melanogaster adults and their larval offspring together engage in ‘niche construction’, facilitating a predictable microbial environment in the fruit substrates in which the larvae live and develop. PMID:22860093

Establishing pan-European clinical trials: regulatory compliance and other practical considerations.

PubMed

Grienenberger, Aurelie

2004-01-01

There are currently many concerns in the pharmaceutical and scientific community working in or around clinical research on the EU Directive 2001/20/EC or Clinical Trials Directive. The Directive introduces regulatory requirements for all phases of study in human subjects, drawing no distinction between commercially funded drug trials and non-commercial/academic research. The Directive makes Good Clinical Practice (GCP) a legal requirement in Europe and all clinical research will be subjected to the same rigorous standards including GCP and Good Manufacturing Practice (GMP) application even at the early clinical phases as well as exhaustive pharmacovigilance and protection of trial subjects. Some of these requirements may be seen as additional burden and a brake to clinical research in Europe. However, the application of the directive should provide a single and highly regulated market of 25 European countries for investigational medicinal products. This article reviews the main aspects and areas of concern of the Directive and provide US sponsor with useful references.

High diversity of protistan plankton communities in remote high mountain lakes in the European Alps and the Himalayan mountains

PubMed Central

Kammerlander, Barbara; Breiner, Hans-Werner; Filker, Sabine; Sommaruga, Ruben; Sonntag, Bettina; Stoeck, Thorsten

2015-01-01

We analyzed the genetic diversity (V4 region of the 18S rRNA) of planktonic microbial eukaryotes in four high mountain lakes including two remote biogeographic regions (the Himalayan mountains and the European Alps) and distinct habitat types (clear and glacier-fed turbid lakes). The recorded high genetic diversity in these lakes was far beyond of what is described from high mountain lake plankton. In total, we detected representatives from 66 families with the main taxon groups being Alveolata (55.0% OTUs97%, operational taxonomic units), Stramenopiles (34.0% OTUs97%), Cryptophyta (4.0% OTUs97%), Chloroplastida (3.6% OTUs97%) and Fungi (1.7% OTUs97%). Centrohelida, Choanomonada, Rhizaria, Katablepharidae and Telonema were represented by <1% OTUs97%. Himalayan lakes harbored a higher plankton diversity compared to the Alpine lakes (Shannon index). Community structures were significantly different between lake types and biogeographic regions (Fisher exact test, P < 0.01). Network analysis revealed that more families of the Chloroplastida (10 vs 5) and the Stramenopiles (14 vs 8) were found in the Himalayan lakes than in the Alpine lakes and none of the fungal families was shared between them. Biogeographic aspects as well as ecological factors such as water turbidity may structure the microbial eukaryote plankton communities in such remote lakes. PMID:25764458

High diversity of protistan plankton communities in remote high mountain lakes in the European Alps and the Himalayan mountains.

PubMed

Kammerlander, Barbara; Breiner, Hans-Werner; Filker, Sabine; Sommaruga, Ruben; Sonntag, Bettina; Stoeck, Thorsten

2015-04-01

We analyzed the genetic diversity (V4 region of the 18S rRNA) of planktonic microbial eukaryotes in four high mountain lakes including two remote biogeographic regions (the Himalayan mountains and the European Alps) and distinct habitat types (clear and glacier-fed turbid lakes). The recorded high genetic diversity in these lakes was far beyond of what is described from high mountain lake plankton. In total, we detected representatives from 66 families with the main taxon groups being Alveolata (55.0% OTUs 97%, operational taxonomic units), Stramenopiles (34.0% OTUs 97%), Cryptophyta (4.0% OTUs 97%), Chloroplastida (3.6% OTUs 97%) and Fungi (1.7% OTUs 97%). Centrohelida, Choanomonada, Rhizaria, Katablepharidae and Telonema were represented by <1% OTUs 97%. Himalayan lakes harbored a higher plankton diversity compared to the Alpine lakes (Shannon index). Community structures were significantly different between lake types and biogeographic regions (Fisher exact test, P < 0.01). Network analysis revealed that more families of the Chloroplastida (10 vs 5) and the Stramenopiles (14 vs 8) were found in the Himalayan lakes than in the Alpine lakes and none of the fungal families was shared between them. Biogeographic aspects as well as ecological factors such as water turbidity may structure the microbial eukaryote plankton communities in such remote lakes. © FEMS 2015.

Reach and its Impact: NASA and US Aerospace Communities

NASA Technical Reports Server (NTRS)

Rothgeb, Matthew J.

2011-01-01

REACH is a European law that threatens to impact materials used within the US aerospace communities, including NASA. The presentation briefly covers REACH and generally, its perceived impacts to NASA and the aerospace community within the US.

The role of COST Actions in unifying the European ionospheric community in the transition between the two millennia

NASA Astrophysics Data System (ADS)

Zolesi, Bruno; Cander, Ljiljana R.

2018-05-01

This paper consists of a review of the important contributions of four COST (European Co-operation in Science and Technology) Actions in the period 1991-2009 to terrestrial ionospheric research, with applications in modern communication and navigation systems. Within this context, new ionospheric studies were initiated, leading to the development of a number of models, algorithms for prediction, forecasting, and real-time specification, as well as numerical programs. These were successfully implemented in different collaborative projects within EU instruments, promoting co-operation between scientists and researchers across Europe. A further outcome was to bring together more than a hundred researchers from around 40 scientific institutions, agencies, and academia in about 25 countries worldwide. They collaborated with enthusiasm in research, as briefly described in this paper, forming a lively ionospheric community and presenting a strong intellectual response to the rapidly growing contemporary challenge of space weather research.

A comprehensive scoring system to measure healthy community design in land use plans and regulations.

PubMed

Maiden, Kristin M; Kaplan, Marina; Walling, Lee Ann; Miller, Patricia P; Crist, Gina

2017-02-01

Comprehensive land use plans and their corresponding regulations play a role in determining the nature of the built environment and community design, which are factors that influence population health and health disparities. To determine the level in which a plan addresses healthy living and active design, there is a need for a systematic, reliable and valid method of analyzing and scoring health-related content in plans and regulations. This paper describes the development and validation of a scoring tool designed to measure the strength and comprehensiveness of health-related content found in land use plans and the corresponding regulations. The measures are scored based on the presence of a specific item and the specificity and action-orientation of language. To establish reliability and validity, 42 land use plans and regulations from across the United States were scored January-April 2016. Results of the psychometric analysis indicate the scorecard is a reliable scoring tool for land use plans and regulations related to healthy living and active design. Intraclass correlation coefficients (ICC) scores showed strong inter-rater reliability for total strength and comprehensiveness. ICC scores for total implementation scores showed acceptable consistency among scorers. Cronbach's alpha values for all focus areas were acceptable. Strong content validity was measured through a committee vetting process. The development of this tool has far-reaching implications, bringing standardization of measurement to the field of land use plan assessment, and paving the way for systematic inclusion of health-related design principles, policies, and requirements in land use plans and their corresponding regulations. Copyright © 2016 Elsevier Inc. All rights reserved.

Regulating chemical hazards in Japan, West Germany, France, the United Kingdom, and the European community: a comparative examination. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coppock, R.

This report is an outgrowth of a National Research Council program initiative to gain a cross-national perspective on the role scientific information has played in hazardous chemical regulation. Although this study is not meant to be evaluative, it is designed to help assess by comparison the decision-making and regulatory mechanisms in U.S. hazard assessment. The chapters on the individual countries are divided into three components: (1) relevant political and administrative traditions that influence expectations about and mechanisms of hazard regulation; (2) a compilation of the relevant statuatory instruments; and (3) the scope of the regulatory jurisdiction. The last category dividesmore » the laws into those which govern industrial plants, emmissions and discharges, worker protection, industrial substances, poisons, agricultural chemicals, food additives, and contaminants, consumer products, transport, chemical waste, and victim compensation. The study concludes with a discussion of ways in which such multinational perspectives might be used to strengthen the regulatory process of the U.S.« less

Multisite comparison of drivers of methane emissions from wetlands in the European Arctic: influence of vegetation community and water table.

NASA Astrophysics Data System (ADS)

Dinsmore, Kerry; Drewer, Julia; Leeson, Sarah; Skiba, Ute; Levy, Pete; George, Charles

2014-05-01

Arctic and sub arctic wetlands are a major source of atmospheric CH4 and therefore have the potential to be important in controlling global radiative forcing. Furthermore, the strong links between wetland CH4 emissions and vegetation community, hydrology and temperature suggest potentially large feedbacks between climate change and future emissions. Quantifying current emissions over large spatial scales and predicting future climatic feedbacks requires a fundamental understanding of the ground based drivers of plot scale emissions. The MAMM project (Methane in the Arctic: Measurements and Modelling) aims to understand and quantify current CH4 emissions and future climatic impacts by combining both ground and aircraft measurements across the European Arctic with regional computer modelling. Here we present results from the ground-based MAMM measurement campaigns, analysing chamber-measured CH4 emissions from two sites in the European Arctic/Sub-Arctic region (Sodankylä, Finland; Stordalen Mire, Sweden) from growing seasons in 2012 and 2013. A total of 85 wetland static chambers were deployed across the two field sites; 39 at Sodankylä (67° 22'01' N, 26° 3'06' E) in 2012 and 46 at Stordalen Mire (68° 21'20' N, 19° 02'56' E) in 2013. Chamber design, protocol and deployment were the same across both sites. Chambers were located at sites chosen strategically to cover the local range of water table depths and vegetation communities. A total of 18 and 15 repeated measurements were made at each chamber in Sodankylä and Stordalen Mire, respectively, over the snow-free season. Preliminary results show a large range of CH4 fluxes across both sites ranging from a CH4 uptake of up to 0.07 and 0.06 mg CH4-C m-2 hr-1 to emissions of 17.3 and 44.2 mg CH4-C m-2 hr-1 in Sodankylä and Stordalen Mire, respectively. Empirical models based on vegetation community, water table depth, temperature and soil nutrient availability (Plant Root Simulator Probes, PRSTM) have been

Knowledge of memory functions in European and Asian American adults and children: the relation to autobiographical memory.

PubMed

Wang, Qi; Koh, Jessie Bee Kim; Song, Qingfang; Hou, Yubo

2015-01-01

This study investigated explicit knowledge of autobiographical memory functions using a newly developed questionnaire. European and Asian American adults (N = 57) and school-aged children (N = 68) indicated their agreement with 13 statements about why people think about and share memories pertaining to four broad functions-self, social, directive and emotion regulation. Children were interviewed for personal memories concurrently with the memory function knowledge assessment and again 3 months later. It was found that adults agreed to the self, social and directive purposes of memory to a greater extent than did children, whereas European American children agreed to the emotion regulation purposes of memory to a greater extent than did European American adults. Furthermore, European American children endorsed more self and emotion regulation functions than did Asian American children, whereas Asian American adults endorsed more directive functions than did European American adults. Children's endorsement of memory functions, particularly social functions, was associated with more detailed and personally meaningful memories. These findings are informative for the understanding of developmental and cultural influences on memory function knowledge and of the relation of such knowledge to autobiographical memory development.

[G. Baglivi and scientific European community between rationalism and enlightenment].

PubMed

Toscano, A

2000-01-01

The Baglivi Correspondence, kept in the Waller Collection at the University Library of Uppsala, has been published in Italy for the first time in 1999. This Correspondence kept in Sweden provides new information about the scientific Italian culture between the second half of the seventeenth century and the beginning of the eighteenth. Moreover, it provides important knowledge on the diffusion the Baglivi's work in the scientific European context at that time.

Topology of the European Network of Earth Observation Networks and the need for an European Network of Networks

NASA Astrophysics Data System (ADS)

Masó, Joan; Serral, Ivette; McCallum, Ian; Blonda, Palma; Plag, Hans-Peter

2016-04-01

ConnectinGEO (Coordinating an Observation Network of Networks EnCompassing saTellite and IN-situ to fill the Gaps in European Observations" is an H2020 Coordination and Support Action with the primary goal of linking existing Earth Observation networks with science and technology (S&T) communities, the industry sector, the Group on Earth Observations (GEO), and Copernicus. The project will end in February 2017. ConnectinGEO will initiate a European Network of Earth Observation Networks (ENEON) that will encompass space-based, airborne and in-situ observations networks. ENEON will be composed of project partners representing thematic observation networks along with the GEOSS Science and Technology Stakeholder Network, GEO Communities of Practices, Copernicus services, Sentinel missions and in-situ support data representatives, representatives of the European space-based, airborne and in-situ observations networks. This communication presents the complex panorama of Earth Observations Networks in Europe. The list of networks is classified by discipline, variables, geospatial scope, etc. We also capture the membership and relations with other networks and umbrella organizations like GEO. The result is a complex interrelation between networks that can not be clearly expressed in a flat list. Technically the networks can be represented as nodes with relations between them as lines connecting the nodes in a graph. We have chosen RDF as a language and an AllegroGraph 3.3 triple store that is visualized in several ways using for example Gruff 5.7. Our final aim is to identify gaps in the EO Networks and justify the need for a more structured coordination between them.

Pharmaceutical policies in European countries.

PubMed

Barros, Pedro Pita

2010-01-01

Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Exploring experts' views and perspectives on the enhancement of Strategic Environmental Assessment in European small islands

DOE Office of Scientific and Technical Information (OSTI.GOV)

Polido, Alexandra, E-mail: a.polido@campus.fct.unl.pt; João, Elsa, E-mail: elsa.joao@strath.ac.uk; Ramos, Tomás B., E-mail: tabr@fct.unl.pt

Small islands have the attention of the international community because they are territories with unique features, and a pressing need for the enhancement of sustainability. Strategic Environmental Assessment (SEA) has characteristics that may promote the development and improvement of sustainability in these territories: (i) changing the mind-set, and the decision-making and institutional paradigm, (ii) facilitating cooperation and coordination between different stakeholders, and (iii) providing a framework for good governance and community empowerment. The scientific literature suggests that there may be a need for context-specific SEA in these territories. However, SEA studies often do not incorporate local contextual information, including intuitivemore » knowledge and sense of place. Therefore, there is a possible gap between what is found in the literature and what local communities think, including different stakeholders and experts. Hence, the main goal of this research was to gain an insight into the views and perspectives of small islands SEA experts about issues related to SEA in European small islands, including context-specific approaches, as well as the contribution of SEA for sustainability in these territories. To achieve the research aim, exploratory research using a questionnaire-based survey was designed, aimed at experts on SEA in European small islands. Findings showed regional cooperation networks may have a fundamental role when developing SEA-specific approaches in these territories. This is because SEA-specific approaches encourage a joint effort among islands within one region to improve SEA capacity-building, develop and share a baseline information system, and to share and exchange resources, overall. Also, guidelines are preferred among experts over more legal frameworks and regulations. Finally, the research showed that experts view SEA as a way to enhance sustainability in small islands. This study highlights the importance of

[European public health professionals express ten priorities for the European Union...to be followed].

PubMed

Oberlé, D; Weil, O; McKee, M; Brodin, M

1999-12-01

Even if the European Union acquired explicit competencies in public health with the Maastricht and Amsterdam Treaties (articles 129 and 152), public health professionals still have not had their word in the definition of public health priorities. Yet it is they, whatever their mission, who must take into consideration the new constraints imposed by Community directives. The French Society for Public Health (FSPH) took the initiative of running a project, financed by the European Commission, aiming to shed light on some of the public health problems considered priority in the 15 member states, and to provide suggestions for facing them. The FSPH adopted a resolutely participative and pragmatic process. At each step (definition of priorities and compiling arguments), the intention of the SFPH was more to allow different, even diverging, points of view to be expressed, than to aim for a hypothetical representativeness. The undertaken themes are the social gradients in health, alcohol, illicit drugs, tobacco, surveillance of health issues, quality of care, older persons, mental health, the environment, nutrition and food security. This work marks the wish of the FSPH for international openness toward Europe. The FSPH hopes that this work becomes a platform for the development of a reinforced dialogue between public health professionals and European decision makers.

Trade-off between taxon diversity and functional diversity in European lake ecosystems.

PubMed

Grossmann, Lars; Beisser, Daniela; Bock, Christina; Chatzinotas, Antonis; Jensen, Manfred; Preisfeld, Angelika; Psenner, Roland; Rahmann, Sven; Wodniok, Sabina; Boenigk, Jens

2016-12-01

Inferring ecosystem functioning and ecosystem services through inspections of the species inventory is a major aspect of ecological field studies. Ecosystem functions are often stable despite considerable species turnover. Using metatranscriptome analyses, we analyse a thus-far unparalleled freshwater data set which comprises 21 mainland European freshwater lakes from the Sierra Nevada (Spain) to the Carpathian Mountains (Romania) and from northern Germany to the Apennines (Italy) and covers an altitudinal range from 38 m above sea level (a.s.l) to 3110 m a.s.l. The dominant taxa were Chlorophyta and streptophytic algae, Ciliophora, Bacillariophyta and Chrysophyta. Metatranscriptomics provided insights into differences in community composition and into functional diversity via the relative share of taxa to the overall read abundance of distinct functional genes on the ecosystem level. The dominant metabolic pathways in terms of the fraction of expressed sequences in the cDNA libraries were affiliated with primary metabolism, specifically oxidative phosphorylation, photosynthesis and the TCA cycle. Our analyses indicate that community composition is a good first proxy for the analysis of ecosystem functions. However, differential gene regulation modifies the relative importance of taxa in distinct pathways. Whereas taxon composition varies considerably between lakes, the relative importance of distinct metabolic pathways is much more stable, indicating that ecosystem functioning is buffered against shifts in community composition through a functional redundancy of taxa. © 2016 The Authors. Molecular Ecology Published by John Wiley & Sons Ltd.

Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.

PubMed

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan.

[Ethical aspects of human embryonic stem cell use and commercial umbilical cord blood stem cell banking. Ethical reflections on the occasion of the regulation of the European Council and Parliament on advanced therapy medicinal products].

PubMed

Virt, G

2010-01-01

The regulation of the European Council and Parliament on advanced therapy medicinal products also includes therapies with human embryonic stem cells. The use of these stem cells is controversially and heavily discussed. Contrary to the use of adult stem cells, medical and ethical problems concerning the use of human embryonic stem cells persists, because this use is based on the destruction of human life at the very beginning. The regulation foresees, therefore, subsidiarity within the European Member States. Although there are no ethical problems in principle with the use of stem cells from the umbilical cord blood, there are social ethical doubts with the banking of these stem cells for autologous use without any currently foreseeable medical advantage by commercial blood banks. Also in this case subsidiarity is valid.

[Recent initiatives of the European Union on the field of drug use and trafficking].

PubMed

Salazar, Lorenzo

2002-01-01

Moving from the general framework offered by the Treaties of the European Union and European Community, the paper presents the more recent specific initiatives of the Union in the field of fight against drugs and in particular on the European Union Plan of Action, adopted by the European Council in June 2000, and on the need for a global and balanced approach which it proposes as the main focus of the action of the European institutions. The paper then examines separately the initiatives taken both at the level of the reduction of the demand, mainly at the preventive and sanitary level, and of the supply reduction, of a mainly repressive character. Conclusively, the main initiatives in the field of international co-operation among the European Union and third Countries.

Underlying Paradox in the European Union's Multilingualism Policies

ERIC Educational Resources Information Center

Johnson, Fern L.

2013-01-01

The European Union (EU) has developed comprehensive policies in recent years to promote multilingualism. In this article, major EU policy statements on multilingualism are analyzed to demonstrate how their underlying language ideology produces paradox by both encouraging multilingualism and regulating its definition within the EU. The first…

Final report of coordination and cooperation with the European Union on embankment failure analysis

USDA-ARS?s Scientific Manuscript database

There has been an emphasis in the European Union (EU) community on the investigation of extreme flood processes and the uncertainties related to these processes. Over a 3-year period, the EU and the U.S. dam safety community (1) coordinated their efforts and collected information needed to integrate...

European Education, European Citizenship? On the Role of Education in Constructing Europeanness.

ERIC Educational Resources Information Center

Ollikainen, Aaro

2000-01-01

Focuses on the role of the European Union (EU) education programs in fostering a sense of European citizenship. Addresses the five meanings given to the concept of European citizenship: (1) recognition of European heritage; (2) EU loyalty; (3) right of free movement; (4) political participation; and (5) active citizenship. (CMK)

Labour migration and the single European market: a synthetic and prospective note.

PubMed

Ardittis, S

1990-12-01

"The present paper is an attempt to analyse and forecast the following major issues relating to migration in Europe after 1992: (i) the evolution and structure of intra-European flows in the forthcoming single European market; (ii) the integration, after 1992, of established immigrant communities, including ethnic minorities and second generation groups; (iii) future immigration from non-EC member states.... The article explains that, in addition to policy-related mutations inherent in the completion of the internal market, other factors (demographic changes and insufficient enrolment of national graduate students in key disciplines) and issues (emergence of atypical groups such as second generation and Eastern European migrants), are due to generate new patterns and modified interests in European labour migration after 1992." excerpt

Community assembly rules affect the diversity of expanding communities.

PubMed

Peng, Zechen; Zhou, Shurong

2014-11-01

Despite centuries of interest in species range limits, few studies have taken a whole community into consideration. Actually, multiple species may simultaneously respond to environmental changes, for example, global warming, leading a series of dynamical communities toward the advancing front. We investigated multiple species range expansions through the analysis of a two-species dispersion model and simulations of multiple species assemblages regulated by neutral and fecundity-survival trade-offs (FSTs), respectively, and found that species assemblages regulated by different mechanisms would initiate different expanding patterns in geographic ranges in response to environmental changes. The neutral model generally predicts a higher biodiversity near the core of an expanding range, and a lower community similarity compared with a FST model. Without considering the evolution of life history traits, an assortment of the reproduction ability happens at the advancing front under FSTs at the expense of a higher death rate or lower competitive ability. These results emphasize the importance of community assembly rules to the biodiversity maintenance of range expanding communities.

A craniometric analysis of early modern Romania and Hungary: The roles of migration and conversion in shaping European Ottoman population history.

PubMed

Allen, Kathryn Grow; von Cramon-Taubadel, Noreen

2017-11-01

Debate persists regarding the biological makeup of European Ottoman communities settled during the expansion of the Ottoman Empire during the 16th and 17th centuries, and the roles of conversion and migration in shaping demography and population history. The aim of this study was to perform an assessment of the biological affinities of three European Ottoman series based on craniometric data. Craniometric data collected from three Ottoman series from Hungary and Romania were compared to European and Anatolian comparative series, selected to represent biological affinity representative of historically recorded migration and conversion influences. Sex-separated samples were analyzed using D 2 -matrices, along with principal coordinates and PERMANOVA analyses to investigate biological affinities. Discriminant function analysis was employed to assign Ottoman individuals to two potential classes: European or Anatolian. Affinity analyses show larger than expected biological differences between males and females within each of the Ottoman communities. Discriminant function analyses show that the majority of Ottoman individuals could be classified as either European or Anatolian with a high probability. Moreover, location within Europe proved influential, as the Ottomans from a location of more geopolitical importance (Budapest) diverged from more hinterland communities in terms of biological affinity patterns. The results suggest that male and female Ottomans may possess distinct population histories, with males and females divergent from each other in terms of their biological affinities. The Ottoman communities appear diverse in terms of constituting a mix of peoples from different biological backgrounds. The greater distances between sexes from the same community, and the differences between communities, may be evidence that the processes of migration and conversion impacted individual people and groups diversely. © 2017 Wiley Periodicals, Inc.

Regulating the advertising of genetic tests in Europe: a balancing act.

PubMed

Kalokairinou, Louiza; Borry, Pascal; Howard, Heidi Carmen

2017-10-01

Direct-to-consumer (DTC) genetic tests (GT) have provoked criticism over their potential adverse impact on public health. The European Parliament called for a ban on DTC advertising of GT during the debate for the adoption of a European Regulation on in vitro diagnostic medical devices. This proposal, however, was not ultimately retained in the final text. Instead, the regulation includes an article prohibiting misleading claims for this kind of advertising. These two different approaches raise questions about the optimal degree of regulation. Herein, we provide an overview of the ways GT have been advertised and related ethical issues. Subsequently, the laws regulating the advertising of GT at the European Union and national level are examined. Finally, recent regulatory developments are discussed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

PubMed

Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

2017-01-01

The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

From heterogeneity to harmonization? Recent trends in European health policy.

PubMed

Gerlinger, Thomas; Urban, Hans-Jürgen

2007-01-01

In the European Union (EU), health policy and the institutional reform of health systems have been treated primarily as national affairs, and health care systems within the EU thus differ considerably. However, the health policy field is undergoing a dynamic process of Europeanization. This process is stimulated by the orientation towards a more competitive economy, recently inaugurated and known as the Lisbon Strategy, while the regulatory requirements of the European Economic and Monetary Union are stimulating the Europeanization of health policy. In addition, the so-called open method of coordination, representing a new mode of regulation within the European multi-level system, is applied increasingly to the health policy area. Diverse trends are thus emerging. While the Lisbon Strategy goes along with a strategic upgrading of health policy more generally, health policy is increasingly used to strengthen economic competitiveness. Pressure on Member States is expected to increase to contain costs and promote market-based health care provision.

Ruminant diets and the Miocene extinction of European great apes

PubMed Central

Merceron, Gildas; Kaiser, Thomas M.; Kostopoulos, Dimitris S.; Schulz, Ellen

2010-01-01

The successful evolutionary radiations of European hominoids and pliopithecoids came to an end during the Late Miocene. Using ruminant diets as environmental proxies, it becomes possible to detect variations in vegetation over time with the potential to explain fluctuations in primate diversity along a NW–SE European transect. Analysis shows that ruminants had diverse diets when primate diversity reached its peak, with more grazers in eastern Europe and more browsers farther west. After the drop in primate diversity, grazers accounted for a greater part of western and central European communities. Eastwards, the converse trend was evident with more browsing ruminants. These opposite trends indicate habitat loss and an increase in environmental uniformity that may have severely favoured the decline of primate diversity. PMID:20519220

Ruminant diets and the Miocene extinction of European great apes.

PubMed

Merceron, Gildas; Kaiser, Thomas M; Kostopoulos, Dimitris S; Schulz, Ellen

2010-10-22

The successful evolutionary radiations of European hominoids and pliopithecoids came to an end during the Late Miocene. Using ruminant diets as environmental proxies, it becomes possible to detect variations in vegetation over time with the potential to explain fluctuations in primate diversity along a NW-SE European transect. Analysis shows that ruminants had diverse diets when primate diversity reached its peak, with more grazers in eastern Europe and more browsers farther west. After the drop in primate diversity, grazers accounted for a greater part of western and central European communities. Eastwards, the converse trend was evident with more browsing ruminants. These opposite trends indicate habitat loss and an increase in environmental uniformity that may have severely favoured the decline of primate diversity.

UK medicines regulation: responding to current challenges.

PubMed

Richards, Natalie; Hudson, Ian

2016-12-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. © 2016 The British Pharmacological Society.

78 FR 79283 - Community Reinvestment Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... thresholds used to define ``small bank'' or ``small savings association'' and ``intermediate small bank'' or ``intermediate small savings association.'' As required by the CRA regulations, the adjustment to the threshold... Agencies' CRA regulations establish CRA performance standards for small and intermediate small banks and...

77 FR 75521 - Community Reinvestment Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... thresholds used to define ``small bank'' or ``small savings association'' and ``intermediate small bank'' or ``intermediate small savings association.'' As required by the CRA regulations, the adjustment to the threshold... intermediate small banks and savings associations. The regulations define small and intermediate small banks...

26 CFR 1.985-8 - Special rules applicable to the European Monetary Union (conversion to euro).

Code of Federal Regulations, 2012 CFR

2012-04-01

... Monetary Union (conversion to euro). 1.985-8 Section 1.985-8 Internal Revenue INTERNAL REVENUE SERVICE... Corporations § 1.985-8 Special rules applicable to the European Monetary Union (conversion to euro). (a... Community which is substituted for the euro in accordance with the Treaty establishing the European...

26 CFR 1.985-8 - Special rules applicable to the European Monetary Union (conversion to euro).

Code of Federal Regulations, 2011 CFR

2011-04-01

... Monetary Union (conversion to euro). 1.985-8 Section 1.985-8 Internal Revenue INTERNAL REVENUE SERVICE... Corporations § 1.985-8 Special rules applicable to the European Monetary Union (conversion to euro). (a... Community which is substituted for the euro in accordance with the Treaty establishing the European...

26 CFR 1.985-8 - Special rules applicable to the European Monetary Union (conversion to euro).

Code of Federal Regulations, 2013 CFR

2013-04-01

... Monetary Union (conversion to euro). 1.985-8 Section 1.985-8 Internal Revenue INTERNAL REVENUE SERVICE... Corporations § 1.985-8 Special rules applicable to the European Monetary Union (conversion to euro). (a... Community which is substituted for the euro in accordance with the Treaty establishing the European...

26 CFR 1.985-8 - Special rules applicable to the European Monetary Union (conversion to euro).

Code of Federal Regulations, 2014 CFR

2014-04-01

... Monetary Union (conversion to euro). 1.985-8 Section 1.985-8 Internal Revenue INTERNAL REVENUE SERVICE... Corporations § 1.985-8 Special rules applicable to the European Monetary Union (conversion to euro). (a... Community which is substituted for the euro in accordance with the Treaty establishing the European...

An Assessment of the Results of European Parliament Elections in Greece and European Union Under the Shadow of Economic Crisis.

PubMed

Fanourgiakis, John; Kanoupakis, Emmanuel

2016-10-01

On January 1, 1981, Greece became the tenth member of the European Economic Community and, 20 years later, on January 1, 2001, joined the euro area. In May of 2010 and February of 2012, Greece signed the first and the second economic adjustment programs and adopted austerity policies throughout the public sector in order to avoid the economic collapse, affecting residents' income and health status. We studied the questionnaires of polls conducted in Greece before the elections of the European Parliament (May 25, 2014) and the "Europeans 2014" Eurobarometer's survey in March of 2014. The responses of Greek voters from the Greek polls were alarming, pointing out their declining personal economic situation and Greece's national economic situation, with a sense that the country was heading in the wrong direction, declaring themselves unsatisfied and insecure. The responses of Greek voters from the "Europeans 2014" survey were even more alarming. Health was the first priority for the voters. As the Greek polls and the Eurobarometer's survey forecasted, but more significantly as the results of the Euro-elections showed, Greek voters preferred to put their hopes in something new. © The Author(s) 2016.

Regulation of stem cell therapies under attack in Europe: for whom the bell tolls

PubMed Central

Bianco, Paolo; Barker, Roger; Brüstle, Oliver; Cattaneo, Elena; Clevers, Hans; Daley, George Q; De Luca, Michele; Goldstein, Lawrence; Lindvall, Olle; Mummery, Christine; Robey, Pamela G; Sattler de Sousa e Brito, Clara; Smith, Austin

2013-01-01

At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation. The scientific community must consider the context—social, financial, medical, legal—in which stem cell science is currently situated and the need for stringent regulation. Additional concerns are emerging. These emanate from the novel climate, created within science itself, and stem cell science in particular, by the currently prevailing model of ‘translational medicine'. Only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients. PMID:23644381

Motivation, Self-Regulated Learning Efficacy, and Academic Achievement among International and Domestic Students at an Urban Community College: A Comparison

ERIC Educational Resources Information Center

Liao, Hsiang-Ann; Ferdenzi, Anita Cuttita; Edlin, Margot

2012-01-01

This study is designed to examine how intrinsic motivation, extrinsic motivation, and self-regulated learning efficacy influence academic achievement of international and domestic community college students. Results show that for both international and domestic students, motivation did not directly affect academic achievement. Self-regulated…

Accelerators for society: succession of European infrastructural projects: CARE, EuCARD, TIARA, EuCARD2

NASA Astrophysics Data System (ADS)

Romaniuk, Ryszard S.

2013-10-01

Accelerator science and technology is one of a key enablers of the developments in the particle physic, photon physics and also applications in medicine and industry. The paper presents a digest of the research results in the domain of accelerator science and technology in Europe, shown during the realization of CARE (Coordinated Accelerator R&D), EuCARD (European Coordination of Accelerator R&D) and during the national annual review meeting of the TIARA - Test Infrastructure of European Research Area in Accelerator R&D. The European projects on accelerator technology started in 2003 with CARE. TIARA is an European Collaboration of Accelerator Technology, which by running research projects, technical, networks and infrastructural has a duty to integrate the research and technical communities and infrastructures in the global scale of Europe. The Collaboration gathers all research centers with large accelerator infrastructures. Other ones, like universities, are affiliated as associate members. TIARA-PP (preparatory phase) is an European infrastructural project run by this Consortium and realized inside EU-FP7. The paper presents a general overview of CARE, EuCARD and especially TIARA activities, with an introduction containing a portrait of contemporary accelerator technology and a digest of its applications in modern society. CARE, EuCARD and TIARA activities integrated the European accelerator community in a very effective way. These projects are expected very much to be continued.

The Creation of the European Social Work Research Association

ERIC Educational Resources Information Center

Taylor, Brian J.; Sharland, Elaine

2015-01-01

As the social work profession matures, the need for robust knowledge becomes more pressing. Greater coordination is required to develop the research community and an infrastructure to support this nationally and internationally. This article discusses the foundation, in 2014, of the European Social Work Research Association and its roots in the…

Towards an integrated European strong motion data distribution

NASA Astrophysics Data System (ADS)

Luzi, Lucia; Clinton, John; Cauzzi, Carlo; Puglia, Rodolfo; Michelini, Alberto; Van Eck, Torild; Sleeman, Reinhoud; Akkar, Sinan

2013-04-01

Recent decades have seen a significant increase in the quality and quantity of strong motion data collected in Europe, as dense and often real-time and continuously monitored broadband strong motion networks have been constructed in many nations. There has been a concurrent increase in demand for access to strong motion data not only from researchers for engineering and seismological studies, but also from civil authorities and seismic networks for the rapid assessment of ground motion and shaking intensity following significant earthquakes (e.g. ShakeMaps). Aside from a few notable exceptions on the national scale, databases providing access to strong motion data has not appeared to keep pace with these developments. In the framework of the EC infrastructure project NERA (2010 - 2014), that integrates key research infrastructures in Europe for monitoring earthquakes and assessing their hazard and risk, the network activity NA3 deals with the networking of acceleration networks and SM data. Within the NA3 activity two infrastructures are being constructed: i) a Rapid Response Strong Motion (RRSM) database, that following a strong event, automatically parameterises all available on-scale waveform data within the European Integrated waveform Data Archives (EIDA) and makes the waveforms easily available to the seismological community within minutes of an event; and ii) a European Strong Motion (ESM) database of accelerometric records, with associated metadata relevant to earthquake engineering and seismology research communities, using standard, manual processing that reflects the state of the art and research needs in these fields. These two separate repositories form the core infrastructures being built to distribute strong motion data in Europe in order to guarantee rapid and long-term availability of high quality waveform data to both the international scientific community and the hazard mitigation communities. These infrastructures will provide the access to

The Role of the European Inspections in the European Educational Space--Echoes from Portugal Regarding the Assessment of Schools

ERIC Educational Resources Information Center

Costa, Estela; Pires, Ana Márcia

2011-01-01

This paper is an approach to the construction of a European educational space (Nóvoa & Lawn, 2002), which is due to new modes of regulation in education. The policy under consideration is the institutional evaluation of schools carried out by the Portuguese General Inspectorate of Education. The aim is to explore how concepts and policies get…

[Characterization of cases contravening of regulations regarding primary aromatic amines originating from azo dyes in commercial textile products and leather products in European Union].

PubMed

Kawakami, Tsuyoshi; Isama, Kazuo; Ikarashi, Yoshiaki

2013-01-01

Contraventions of regulations regarding primary aromatic amines (PAAs) originating from azo dyes in commercial textile products and leather products in European Union (EU), notified in the period between 2006 and 2012 were collected from the Rapid Alert System for non-food consumer products (RAPEX), were characterized. Various types of products (clothes, footwear, bedding, etc.) and their raw materials (cotton, silk, viscose, leather, etc.) were reported to have contravened the regulations. The contravention frequencies for products made in China and India were higher than those for other countries. Ten percentage of the country in which the reported products were produced was unknown. The notification frequencies for benzidine and 4-aminoazobenzene were higher than those for other PAAs. Contravention of regulations regarding benzidine, 4-aminoazobenzene, and 3,3'-dimethoxybenzidine were notified every year. Contraventions of regulations regarding five PAAs--classified as IARC group 1--were notified one or several times. Since the scale of the survey conducted in Japan were small compared with RAPEX, it is necessary that many kinds and number of products should be surveyed in Japan. In addition, it is also necessary to pay attention to 4-aminoazobenzene, while it has not been detected in the previous studies conducted in Japan.

Geographical assemblages of European raptors and owls

NASA Astrophysics Data System (ADS)

López-López, Pascual; Benavent-Corai, José; García-Ripollés, Clara

2008-09-01

In this work we look for geographical structure patterns in European raptors (Order: Falconiformes) and owls (Order: Strigiformes). For this purpose we have conducted our research using freely available tools such as statistical software and databases. To perform the study, presence-absence data for the European raptors and owl species (Class Aves) were downloaded from the BirdLife International website. Using the freely available "pvclust" R-package, we applied similarity Jaccard index and cluster analysis in order to delineate biogeographical relationships for European countries. According to the cluster of similarity, we found that Europe is structured into two main geographical assemblages. The larger length branch separated two main groups: one containing Iceland, Greenland and the countries of central, northern and northwestern Europe, and the other group including the countries of eastern, southern and southwestern Europe. Both groups are divided into two main subgroups. According to our results, the European raptors and owls could be considered structured into four meta-communities well delimited by suture zones defined by Remington (1968) [Remington, C.L., 1968. Suture-zones of hybrid interaction between recently joined biotas. Evol. Biol. 2, 321-428]. Climatic oscillations during the Quaternary Ice Ages could explain at least in part the modern geographical distribution of the group.

Orphan Drug Regulation: A missed opportunity for children and adolescents with cancer.

PubMed

Vassal, Gilles; Kearns, Pam; Blanc, Patricia; Scobie, Nicole; Heenen, Delphine; Pearson, Andy

2017-10-01

Oncology represents a major sector in the field of orphan drug development in Europe. The objective was to evaluate whether children and adolescents with cancer benefited from the Orphan Drug Regulation. Data on orphan drug designations (ODDs) and registered orphan drugs from 8th August 2000 to 10th September 2016 were collected from the Community Register of medicinal products for human use. Assessment history, product information and existence of paediatric investigation plans were searched and retrieved from the European Medicine Agency website. Over 16 years, 272 of 657 oncology ODDs (41%) concerned a malignant condition occurring both in adults and children. The five most common were acute myeloid leukaemia, high-grade glioma, acute lymphoblastic leukaemia, graft-versus-host disease and soft-tissue sarcomas. 74% of 31 marketing authorisations (MAs) for an indication both in adults and children (26 medicines) had no information for paediatric use in their Summary of Product Characteristics (SmPC) at the time of the first MA. Furthermore, 68% still have no paediatric information in their most recently updated SmPC, at a median of 7 years after. Only 15 ODDs (2%) pertained to a malignancy occurring specifically in children and only two drugs received an MA: Unituxin for high-risk neuroblastoma and Votubia for sub-ependymal giant-cell astrocytoma. The Orphan Drug Regulation failed to promote the development of innovative therapies for malignancies occurring in children. Major delays and waivers occurred through the application of the Paediatric Medicines Regulation. The European regulatory environment needs to be improved to accelerate innovation for children and adolescents dying of cancer. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

PubMed Central

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. PMID:25342901

Adding value to figures: a web-based European public health information system.

PubMed

van der Wilk, Eveline A; Verschuuren, Marieke

2010-01-01

In 2008 a prototype, web-based system was launched which provided information for different user groups interested in European public health topics. The EUPHIX system contained scientifically sound data, with presentations as well as textual information. The information was structured according to the European Community Health Indicators (ECHI) shortlist. The information included different types of data presentations (tables, interactive graphs and maps), explanatory texts and overviews of the data sources and the literature used. The content was produced by a network of European experts according to a structured, peer-reviewed editorial process. Thus EUPHIX provided an easily accessible, comprehensive, state-of-the-art information source. To ensure that it will continue, financial support will be needed. Co-ownership by the European Commission and the Member States seems an appropriate solution.

European experience of regulating distance selling of medicines for Ukraine.

PubMed

Pashkov, Vitalii; Hrekov, Yevhen; Hrekova, Maryna

Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.

Do informal caregivers for elderly in the community use support measures? A qualitative study in five European countries.

PubMed

Willemse, Evi; Anthierens, Sibyl; Farfan-Portet, Maria Isabel; Schmitz, Olivier; Macq, Jean; Bastiaens, Hilde; Dilles, Tinne; Remmen, Roy

2016-07-16

Informal caregivers are essential figures for maintaining frail elderly at home. Providing informal care can affect the informal caregivers' physical and psychological health and labour market participation capabilities. They need support to prevent caregiver burden. A variety of existing support measures can help the caregiver care for the elderly at home, but with some limitations. The objective of this review was to explore the experiences of informal caregivers caring for elderly in the community with the use of supportive policy measures in Belgium and compare these to the experiences in other European countries. An empirical qualitative case study research was conducted in five European countries (Belgium, The Netherlands, Luxembourg, France and Germany). Semi-structured interviews were conducted with informal caregivers and their dependent elderly. Interview data from the different cases were analysed. In particular data from Belgium was compared to data from the cases abroad. Formal services (e.g. home care) were reported to have the largest impact on allowing the caregiver to care for the dependent elderly at home. One of the key issues in Belgium is the lack of timely access to reliable information about formal and informal services in order to proactively support the informal caregiver. Compared to the other countries, informal caregivers in Belgium expressed more difficulties in accessing support measures and navigating through the health system. In the other countries information seemed to be given more timely when home care was provided via care packages. To support the informal caregiver, who is the key person to support the frail elderly, fragmentation of information regarding supportive policy measures is an important issue of concern.

Substance abuse prevention in American Indian and Alaska Native communities.

PubMed

Whitbeck, Les B; Walls, Melissa L; Welch, Melissa L

2012-09-01

In this article we review three categories of American Indian/Alaska Native (AIAN) substance abuse prevention programs: (1) published empirical trials; (2) promising programs published and unpublished that are in the process of development and that have the potential for empirical trials; and (3) examples of innovative grassroots programs that originate at the local level and may have promise for further development. AIAN communities are taking more and more independent control of substance abuse prevention. We point out that European American prevention scientists are largely unaware of the numerous grassroots prevention work going on in AIAN communities and urge a paradigm shift from adapting European American prevention science "best practices" to creating cultural "best practices" by working from inside AIAN communities.

'Children and obesity: a pan-European project examining the role of food marketing'.

PubMed

Matthews, Anne E

2008-02-01

Rising levels of obesity in school-age children across Europe are causing increasing concern. The 'Children, Obesity and associated avoidable Chronic Diseases' project sought to examine the effects of promotion within food marketing, given the influential role it plays in children's diets. A questionnaire and data-collection protocol was designed for the national co-ordinators, facilitating standardized responses. Co-ordinators collected data from within 20 European Union countries relating to food promotion to children. Results showed that unhealthy foods such as savoury snacks and confectionary were the most commonly marketed and consumed by children across all countries. Television was found to be the prime promotional medium, with in-school and internet marketing seen as growth areas. Media literacy programmes designed specifically to counterbalance the effects of food marketing to children were reported by only a few of the 20 countries. An ineffective and incoherent pattern of regulation was observed across the countries as few governments imposed tough restrictions with most preferring to persuade industry to voluntarily act with responsibly. Most health, consumer and public interest groups supported food marketing restrictions whilst industry and media groups advocated self-regulation. Recommendations include the amendment of the European Union's Television Without Frontiers Directive to ban all TV advertising of unhealthy food to children, the adoption of a commonly agreed European Union definition of an 'unhealthy' food, and the establishment of a mechanism for pan-European monitoring of the nature and extent of food marketing to children and its regulation.

A survey of nursing documentation, terminologies and standards in European countries

PubMed Central

Thoroddsen, Asta; Ehrenberg, Anna; Sermeus, Walter; Saranto, Kaija

2012-01-01

A survey was carried out to describe the current state of art in the use of nursing documentation, terminologies, standards and education. Key informants in European countries were targeted by the Association for Common European Nursing Diagnoses, Interventions and Outcomes (ACENDIO). Replies were received from key informants in 20 European countries. Results show that the nursing process was most often used to structure nursing documentation. Many standardized nursing terminologies were used in Europe with NANDA, NIC, NOC and ICF most frequently used. In 70% of the countries minimum requirements were available for electronic health records (EHR), but nursing not addressed specifically. Standards in use for nursing terminologies and information systems were lacking. The results should be a major concern to the nursing community in Europe. As a European platform, ACENDIO can play a role in enhancing standardization activities, and should develop its role accordingly. PMID:24199130

Nitrogen Addition Regulates Soil Nematode Community Composition through Ammonium Suppression

PubMed Central

Wei, Cunzheng; Zheng, Huifen; Li, Qi; Lü, Xiaotao; Yu, Qiang; Zhang, Haiyang; Chen, Quansheng; He, Nianpeng; Kardol, Paul; Liang, Wenju; Han, Xingguo

2012-01-01

Nitrogen (N) enrichment resulting from anthropogenic activities has greatly changed the composition and functioning of soil communities. Nematodes are one of the most abundant and diverse groups of soil organisms, and they occupy key trophic positions in the soil detritus food web. Nematodes have therefore been proposed as useful indicators for shifts in soil ecosystem functioning under N enrichment. Here, we monitored temporal dynamics of the soil nematode community using a multi-level N addition experiment in an Inner Mongolia grassland. Measurements were made three years after the start of the experiment. We used structural equation modeling (SEM) to explore the mechanisms regulating nematode responses to N enrichment. Across the N enrichment gradient, significant reductions in total nematode abundance, diversity (H' and taxonomic richness), maturity index (MI), and the abundance of root herbivores, fungivores and omnivores-predators were found in August. Root herbivores recovered in September, contributing to the temporal variation of total nematode abundance across the N gradient. Bacterivores showed a hump-shaped relationship with N addition rate, both in August and September. Ammonium concentration was negatively correlated with the abundance of total and herbivorous nematodes in August, but not in September. Ammonium suppression explained 61% of the variation in nematode richness and 43% of the variation in nematode trophic group composition. Ammonium toxicity may occur when herbivorous nematodes feed on root fluid, providing a possible explanation for the negative relationship between herbivorous nematodes and ammonium concentration in August. We found a significantly positive relationship between fungivores and fungal phospholipid fatty acids (PLFA), suggesting bottom-up control of fungivores. No such relationship was found between bacterivorous nematodes and bacterial PLFA. Our findings contribute to the understanding of effects of N enrichment in

The Unions and the Relaunching of European Social Policy

ERIC Educational Resources Information Center

Guasconi, Maria Eleonora

2004-01-01

The question of European trade unions' approach towards vocational training is an interesting example of a broader issue, involving both the role played by non-governmental actors in shaping the social dimension of the integration process, and the need to develop a social dialogue in the Community. In this context, the establishment of Cedefop in…

32 CFR 705.22 - Relations with community groups.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Relations with community groups. 705.22 Section... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.22 Relations with community groups. (a) Naval commands will cooperate with and assist community groups within their capabilities, to the event...

32 CFR 705.22 - Relations with community groups.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 5 2013-07-01 2013-07-01 false Relations with community groups. 705.22 Section... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.22 Relations with community groups. (a) Naval commands will cooperate with and assist community groups within their capabilities, to the event...

32 CFR 705.22 - Relations with community groups.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 5 2014-07-01 2014-07-01 false Relations with community groups. 705.22 Section... REGULATIONS AND OFFICIAL RECORDS PUBLIC AFFAIRS REGULATIONS § 705.22 Relations with community groups. (a) Naval commands will cooperate with and assist community groups within their capabilities, to the event...

Plants regulate the effects of experimental warming on the soil microbial community in an alpine scrub ecosystem.

PubMed

Ma, Zhiliang; Zhao, Wenqiang; Zhao, Chunzhang; Wang, Dong; Liu, Mei; Li, Dandan; Liu, Qing

2018-01-01

Information on how soil microbial communities respond to warming is still scarce for alpine scrub ecosystems. We conducted a field experiment with two plant treatments (plant removal or undisturbed) subjected to warmed or unwarmed conditions to examine the effects of warming and plant removal on soil microbial community structures during the growing season in a Sibiraea angustata scrubland of the eastern Qinghai-Tibetan Plateau. The results indicate that experimental warming significantly influenced soil microbial biomass carbon (MBC) and microbial biomass nitrogen (MBN), but the warming effects were dependent on the plant treatments and sampling seasons. In the plant-removal plots, warming did not affect most of the microbial variables, while in the undisturbed plots, warming significantly increased the abundances of actinomycete and Gram-positive bacterial groups during the mid-growing season (July), but it did not affect the fungi groups. Plant removal significantly reduced fungal abundance throughout the growing season and significantly altered the soil microbial community structure in July. The interaction between warming and plant removal significantly influenced the soil MBC and MBN and the abundances of total microbes, bacteria and actinomycete throughout the growing season. Experimental warming significantly reduced the abundance of rare taxa, while the interaction between warming and plant removal tended to have strong effects on the abundant taxa. These findings suggest that the responses of soil microbial communities to warming are regulated by plant communities. These results provide new insights into how soil microbial community structure responds to climatic warming in alpine scrub ecosystems.

Plants regulate the effects of experimental warming on the soil microbial community in an alpine scrub ecosystem

PubMed Central

Ma, Zhiliang; Zhao, Wenqiang; Zhao, Chunzhang; Wang, Dong; Liu, Mei; Li, Dandan

2018-01-01

Information on how soil microbial communities respond to warming is still scarce for alpine scrub ecosystems. We conducted a field experiment with two plant treatments (plant removal or undisturbed) subjected to warmed or unwarmed conditions to examine the effects of warming and plant removal on soil microbial community structures during the growing season in a Sibiraea angustata scrubland of the eastern Qinghai–Tibetan Plateau. The results indicate that experimental warming significantly influenced soil microbial biomass carbon (MBC) and microbial biomass nitrogen (MBN), but the warming effects were dependent on the plant treatments and sampling seasons. In the plant-removal plots, warming did not affect most of the microbial variables, while in the undisturbed plots, warming significantly increased the abundances of actinomycete and Gram-positive bacterial groups during the mid-growing season (July), but it did not affect the fungi groups. Plant removal significantly reduced fungal abundance throughout the growing season and significantly altered the soil microbial community structure in July. The interaction between warming and plant removal significantly influenced the soil MBC and MBN and the abundances of total microbes, bacteria and actinomycete throughout the growing season. Experimental warming significantly reduced the abundance of rare taxa, while the interaction between warming and plant removal tended to have strong effects on the abundant taxa. These findings suggest that the responses of soil microbial communities to warming are regulated by plant communities. These results provide new insights into how soil microbial community structure responds to climatic warming in alpine scrub ecosystems. PMID:29668711

Food culture in the home environment: family meal practices and values can support healthy eating and self-regulation in young people in four European countries.

PubMed

de Wit, John B F; Stok, F Marijn; Smolenski, Derek J; de Ridder, Denise D T; de Vet, Emely; Gaspar, Tania; Johnson, Fiona; Nureeva, Lyliya; Luszczynska, Aleksandra

2015-03-01

Overweight epidemics, including among children and adolescents, are fuelled by contemporary obesogenic environments. Recent research and theory highlight the importance of socio-cultural factors in mitigating adverse impacts of the abundance of food in high-income countries. The current study examines whether family meal culture shapes young people's eating behaviors and self-regulation. Young people aged 10-17 years were recruited through schools in four European countries: the Netherlands, Poland, Portugal and the United Kingdom. A total of 2,764 participants (mean age 13.2 years; 49.1% girls) completed a self-report questionnaire in class, providing information on healthy and unhealthy eating, joint family meals and communal meal values and use of eating-related self-regulation strategies. Path analysis found that family meal culture variables were significantly associated with young people's eating behaviors, as was self-regulation. Significant indirect effects of family meal culture were also found, through self-regulation. Results confirm that family meal culture, encompassing values as well as practices, shapes young people's eating behaviors. Findings extend and link previously separate lines of enquiry by showing how food cultures can play out in the home environment. Importantly, the study contributes novel evidence suggesting that self-regulation is shaped by the home environment and mediates its influence. © 2014 The International Association of Applied Psychology.

Ethnic Variation in Depressive Symptoms in a Community Sample in Hawai‘i

PubMed Central

Kanazawa, Asako; White, Patricia M.; Hampson, Sarah E.

2008-01-01

A modified CES-D was administered to a community sample of 176 European Americans (EA), 209 Native Hawaiians (NH), and 357 Japanese Americans (JA), yielding measures of depression, positive affect, depressed affect, somatic disturbance and disturbed interpersonal relations. Positive affect was lower in JA relative to EA, consistent with findings among Native Japanese, a pattern attributed to cultural variation in emotion regulation. NH reported lower positive affect than EA, accompanied by elevated negative affect and somatic disturbance, suggesting generally higher levels of depressive symptoms. The three ethnic groups varied in mental healthcare usage with differing associations between depressive symptoms and experiences of stressful life events. Taken together, these results suggest ethnic variation in depressive symptoms may arise from differing cultural beliefs. PMID:17227175

Biosimilars: A consideration of the regulations in the United States and European union.

PubMed

Daller, Justin

2016-04-01

Biosimilars are defined as biological products that are highly similar to a reference product, notwithstanding minor differences in clinically inactive components. Biosimilars show no clinically meaningful differences in safety, purity, and potency of the product in comparison to the reference product. With the ever looming patent expiry of some major high cost biologics, biosimilar production is becoming ever more lucrative to companies. Europe (EU) set the precedent, followed by the United States (US) in early 2012, for the approval process for biosimilars. Therefore, the purpose of this paper is to explore the nature of the regulatory processes in the US and EU and to determine the requirements of each in the approval process of a biosimilar. The current Food and Drug Administration (FDA) and European Medicines Agency's (EMA) guidance documents for biosimilars were reviewed revealing a need for further clarifications, as well as specifically addressing Celltrion's and Sandoz's application for approval for the biosimilars infliximab and filgrastim, respectively. Currently, the FDA and EMA focus on comparability in terms of the clinical, pharmacokinetic (PK)/pharmacodynamic (PD), preclinical, biological activity, and physiochemical characterization results, as well as requiring a robust and consistent manufacturing process. Both the EU and US have prepared guidance documents for biosimilars that will result in biotherapeutics that are as safe and efficacious as the innovator product but the necessity exists to globally harmonize international nonproprietary naming nomenclature and clarify how the concept of pharmacovigilance, extrapolation, and interchangeability will be handled and regulated in the future. Copyright © 2015 Elsevier Inc. All rights reserved.

Community Characteristics and Leaf Stoichiometric Traits of Desert Ecosystems Regulated by Precipitation and Soil in an Arid Area of China.

PubMed

Zhang, Xiaolong; Guan, Tianyu; Zhou, Jihua; Cai, Wentao; Gao, Nannan; Du, Hui; Jiang, Lianhe; Lai, Liming; Zheng, Yuanrun

2018-01-10

Precipitation is a key environmental factor determining plant community structure and function. Knowledge of how community characteristics and leaf stoichiometric traits respond to variation in precipitation is crucial for assessing the effects of global changes on terrestrial ecosystems. In this study, we measured community characteristics, leaf stoichiometric traits, and soil properties along a precipitation gradient (35-209 mm) in a desert ecosystem of Northwest China to explore the drivers of these factors. With increasing precipitation, species richness, aboveground biomass, community coverage, foliage projective cover (FPC), and leaf area index (LAI) all significantly increased, while community height decreased. The hyperarid desert plants were characterized by lower leaf carbon (C) and nitrogen/phosphorus (N/P) levels, and stable N and P, and these parameters did not change significantly with precipitation. The growth of desert plants was limited more by N than P. Soil properties, rather than precipitation, were the main drivers of desert plant leaf stoichiometric traits, whereas precipitation made the biggest contribution to vegetation structure and function. These results test the importance of precipitation in regulating plant community structure and composition together with soil properties, and provide further insights into the adaptive strategy of communities at regional scale in response to global climate change.

Community Characteristics and Leaf Stoichiometric Traits of Desert Ecosystems Regulated by Precipitation and Soil in an Arid Area of China

PubMed Central

Guan, Tianyu; Zhou, Jihua; Cai, Wentao; Gao, Nannan; Du, Hui; Jiang, Lianhe; Lai, Liming; Zheng, Yuanrun

2018-01-01

Precipitation is a key environmental factor determining plant community structure and function. Knowledge of how community characteristics and leaf stoichiometric traits respond to variation in precipitation is crucial for assessing the effects of global changes on terrestrial ecosystems. In this study, we measured community characteristics, leaf stoichiometric traits, and soil properties along a precipitation gradient (35–209 mm) in a desert ecosystem of Northwest China to explore the drivers of these factors. With increasing precipitation, species richness, aboveground biomass, community coverage, foliage projective cover (FPC), and leaf area index (LAI) all significantly increased, while community height decreased. The hyperarid desert plants were characterized by lower leaf carbon (C) and nitrogen/phosphorus (N/P) levels, and stable N and P, and these parameters did not change significantly with precipitation. The growth of desert plants was limited more by N than P. Soil properties, rather than precipitation, were the main drivers of desert plant leaf stoichiometric traits, whereas precipitation made the biggest contribution to vegetation structure and function. These results test the importance of precipitation in regulating plant community structure and composition together with soil properties, and provide further insights into the adaptive strategy of communities at regional scale in response to global climate change. PMID:29320458

Scientific Method and the Regulation of Health and Nutritional Claims by the European Food Safety Authority

ERIC Educational Resources Information Center

Hoad, Darren

2011-01-01

The protection of European consumers from the false or misleading scientific and nutritional claims of food manufacturers took a step forward with the recent opinions of the European Food Safety Authority (EFSA). As a risk assessment agency, the EFSA recently assessed and rejected a vast number of food claim forcing the withdrawal of many claims…

[The control of foodstuffs at the beginning of 1993].

PubMed

Babusiaux, C

1992-11-01

The 1st January 1993 the frontiers between the Member States of the European Community and the customs controls will disappear. The abolition of this type of control won't affect the food security. The french administration has strong legal rules to ensure the protection of consumer's health. The regulations prepared by European Community in order to allow the free circulation of goods also ensure a high level of consumer's protection. In case of harmonization, each Member state keeps some rights when there are risks for consumer's health. In absence of community regulations the principal of mutual acknowledgement aiming to avoid the barriers to trade can then not be applied for health and security necessities. The authorities controls are now resolutely inserted in an european context: priority to controls during production, harmonized methods of intervention to promote the required acknowledgement of controls enforced in each Member state, involvement in an european alert system, and development of the cooperation between the national administrative authorities of inspection. Regarding the matter of food security the authorities need the assistance of the scientific community and of its national and international representative organisations. They take an essential part in diagnosing, emergency and advice during the elaboration of regulations. Their power should be even greater with the implementation of the european scientific cooperation.

Effects of microplastics on European flat oysters, Ostrea edulis and their associated benthic communities.

PubMed

Green, Dannielle Senga

2016-09-01

Plastic pollution is recognised as an emerging threat to aquatic ecosystems, with microplastics now the most abundant type of marine debris. Health effects caused by microplastics have been demonstrated at the species level, but impacts on ecological communities remain unknown. In this study, impacts of microplastics on the health and biological functioning of European flat oysters (Ostrea edulis) and on the structure of associated macrofaunal assemblages were assessed in an outdoor mesocosm experiment using intact sediment cores. Biodegradable and conventional microplastics were added at low (0.8 μg L(-1)) and high (80 μg L(-1)) doses in the water column repeatedly for 60 days. Effects on the oysters were minimal, but benthic assemblage structures differed and species richness and the total number of organisms were ∼1.2 and 1.5 times greater in control mesocosms than in those exposed to high doses of microplastics. Notably, abundances of juvenile Littorina sp. (periwinkles) and Idotea balthica (an isopod) were ∼2 and 8 times greater in controls than in mesocosms with the high dose of either type of microplastic. In addition, the biomass of Scrobicularia plana (peppery furrow shell clam) was ∼1.5 times greater in controls than in mesocosms with the high dose of microplastics. This work indicates that repeated exposure to high concentrations of microplastics could alter assemblages in an important marine habitat by reducing the abundance of benthic fauna. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Rules and regulations applying to incidents in radiotherapy].

PubMed

Lohr, F; Baus, W; Vorwerk, H; Schlömp, B; André, L; Georg, D; Hodapp, N

2012-07-01

Radiotherapy is an essential and reliable element of the treatment armamentarium in oncology. Numerous rules, regulations, and protocols minimize the associated risks. It can, however, never be excluded that errors in the treatment delivery chain result in inadequate tumor doses or unnecessary damage to organs at risk. A legal framework governs the management of such incidents. The most important European and North American regulations are reported. Various directives issued by the European Union are differently implemented nationally. This applies particularly to the characterization of incidents that must be reported to authorities. Reporting thresholds, audit systems, and the extent of the integration of voluntary reporting systems vary. Radiotherapy incidents are dealt with differently on an international level. Changes are to be expected based on the European Basic Safety Standards Directive that is currently being prepared and will have to be implemented nationally in due course.

The Place of Vocational Training in Francois Mitterrand's Idea of a European Social Space (1981-1984)

ERIC Educational Resources Information Center

Saunier, Georges

2004-01-01

Between 1981 and 1984, during the budgetary crisis of the European Community, significant negotiations were held between the Ten in connection with the reform of the European Social Fund. At the same time, there was a major political change in France: the left--led by Francois Mitterrand--came to power. In the social field, Francois Mitterrand had…

Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States.

PubMed

Ivaskiene, Tatjana; Mauricas, Mykolas; Ivaska, Justinas

2017-01-01

Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.

Data Networking for the European Academic and Research Community: Is It Important?

ERIC Educational Resources Information Center

Williams, David O.; Carpenter, Brian E.

1992-01-01

Discussion of data networking in Europe provides background on the current situation in the United States and the Pacific region. The situation in Europe is then addressed, including the present status of national networks, disciplinary networks, and the European Internet; regulatory, political, economic, and technical barriers to progress; and…

Community based monitoring: engaging and empowering Alberta ranchers

Treesearch

Michael S. Quinn; Jennifer E. Dubois

2005-01-01

Community based monitoring (CBM), a form of citizen science, is presented as a potential contributor to ecosystem management and sustainable development. A conceptual model for CBM and lessons learned from a Canadian national pilot program, the Canadian Community Monitoring Network, are summarized along with a description of the European university-based “science shop...

[European community guidelines and standards in indoor air quality: what proposals for Italy].

PubMed

Settimo, Gaetano; D'Alessandro, Daniela

2014-01-01

Indoor air quality is an issue on which to focus because of the increasing number of exposed population and in view of the strong public feeling on this issue. This paper reports the rules of EU and several European countries about indoor air quality, focusing on the initiatives performed in Italy to respond to WHO recommendations. Several EU countries have introduced in their legislation rules relating to indoor air quality. At the moment, in Italy, a reference rule has not been issued. For this reason, up to date main informations concerning some guidelines or reference values in indoor air, to be used for a first comparison, are those obtained by the scientific literature, or by the guidelines issued by other European countries or, for analogy, by other standard values such as limit or reference values regarding outdoor air. Even the EU, while reaffirming the priority of energy efficiency measures, recommends healthier indoor environments and the development of a specific European strategy on the issue of indoor air quality. The National Study Group on indoor pollution of the Italian National Health Institute (ISS), is working for the development of shared technical and scientific documents, in order to provide greater uniformity of actions at national level, waiting for a legal framework for indoor air quality, in the light of the indication already produced by the WHO.

Cuticles of European and American lobsters harbor diverse bacterial species and differ in disease susceptibility

PubMed Central

Whitten, Miranda M A; Davies, Charlotte E; Kim, Anita; Tlusty, Michael; Wootton, Emma C; Chistoserdov, Andrei; Rowley, Andrew F

2014-01-01

Diseases of lobster shells have a significant impact on fishing industries but the risk of disease transmission between different lobster species has yet to be properly investigated. This study compared bacterial biofilm communities from American (Homarus americanus) and European lobsters (H. gammarus), to assess both healthy cuticle and diseased cuticle during lesion formation. Culture-independent molecular techniques revealed diversity in the bacterial communities of cuticle biofilms both within and between the two lobster species, and identified three bacterial genera associated with shell lesions plus two putative beneficial bacterial species (detected exclusively in healthy cuticle or healing damaged cuticle). In an experimental aquarium shared between American and European lobsters, heterospecific transmission of potentially pathogenic bacteria appeared to be very limited; however, the claws of European lobsters were more likely to develop lesions when reared in the presence of American lobsters. Aquarium biofilms were also examined but revealed no candidate pathogens for environmental transmission. Aquimarina sp. ‘homaria’ (a potential pathogen associated with a severe epizootic form of shell disease) was detected at a much higher prevalence among American than European lobsters, but its presence correlated more with exacerbation of existing lesions rather than with lesion initiation. PMID:24817518

Distinguishing community benefits: tax exemption versus organizational legitimacy.

PubMed

Byrd, James D; Landry, Amy

2012-01-01

US policymakers continue to call into question the tax-exempt status of hospitals. As nonprofit tax-exempt entities, hospitals are required by the Internal Revenue Service (IRS) to report the type and cost of community benefits they provide. Institutional theory indicates that organizations derive organizational legitimacy from conforming to the expectations of their environment. Expectations from the state and federal regulators (the IRS, state and local taxing authorities in particular) and the community require hospitals to provide community benefits to achieve legitimacy. This article examines community benefit through an institutional theory framework, which includes regulative (laws and regulation), normative (certification and accreditation), and cultural-cognitive (relationship with the community including the provision of community benefits) pillars. Considering a review of the results of a 2006 IRS study of tax-exempt hospitals, the authors propose a model of hospital community benefit behaviors that distinguishes community benefits between cost-quantifiable activities appropriate for justifying tax exemption and unquantifiable activities that only contribute to hospitals' legitimacy.

Fault2SHA- A European Working group to link faults and Probabilistic Seismic Hazard Assessment communities in Europe

NASA Astrophysics Data System (ADS)

Scotti, Oona; Peruzza, Laura

2016-04-01

The key questions we ask are: What is the best strategy to fill in the gap in knowledge and know-how in Europe when considering faults in seismic hazard assessments? Are field geologists providing the relevant information for seismic hazard assessment? Are seismic hazard analysts interpreting field data appropriately? Is the full range of uncertainties associated with the characterization of faults correctly understood and propagated in the computations? How can fault-modellers contribute to a better representation of the long-term behaviour of fault-networks in seismic hazard studies? Providing answers to these questions is fundamental, in order to reduce the consequences of future earthquakes and improve the reliability of seismic hazard assessments. An informal working group was thus created at a meeting in Paris in November 2014, partly financed by the Institute of Radioprotection and Nuclear Safety, with the aim to motivate exchanges between field geologists, fault modellers and seismic hazard practitioners. A variety of approaches were presented at the meeting and a clear gap emerged between some field geologists, that are not necessarily familiar with probabilistic seismic hazard assessment methods and needs and practitioners that do not necessarily propagate the "full" uncertainty associated with the characterization of faults. The group thus decided to meet again a year later in Chieti (Italy), to share concepts and ideas through a specific exercise on a test case study. Some solutions emerged but many problems of seismic source characterizations with people working in the field as well as with people tackling models of interacting faults remained. Now, in Wien, we want to open the group and launch a call for the European community at large to contribute to the discussion. The 2016 EGU session Fault2SHA is motivated by such an urgency to increase the number of round tables on this topic and debate on the peculiarities of using faults in seismic hazard

Cultivation of Special Needs Students' Citizenship as the Basis in the Aspiration of Ukraine to European Integration

ERIC Educational Resources Information Center

Fedorova, Yevhenia

2014-01-01

The prospects for the cultivation of special needs students' citizenship as a prerequisite for the entry of Ukraine into the European Community have been described. The priority of compliance of European democratic sociocultural standards and humanistic values, among which the most important are the changes of attitude towards the disabled people,…

Mechanisms and Regulation of Extracellular DNA Release and Its Biological Roles in Microbial Communities

PubMed Central

Ibáñez de Aldecoa, Alejandra L.; Zafra, Olga; González-Pastor, José E.

2017-01-01

The capacity to release genetic material into the extracellular medium has been reported in cultures of numerous species of bacteria, archaea, and fungi, and also in the context of multicellular microbial communities such as biofilms. Moreover, extracellular DNA (eDNA) of microbial origin is widespread in natural aquatic and terrestrial environments. Different specific mechanisms are involved in eDNA release, such as autolysis and active secretion, as well as through its association with membrane vesicles. It is noteworthy that in microorganisms, in which DNA release has been studied in detail, the production of eDNA is coordinated by the population when it reaches a certain cell density, and is induced in a subpopulation in response to the accumulation of quorum sensing signals. Interestingly, in several bacteria there is also a relationship between eDNA release and the development of natural competence (the ability to take up DNA from the environment), which is also controlled by quorum sensing. Then, what is the biological function of eDNA? A common biological role has not been proposed, since different functions have been reported depending on the microorganism. However, it seems to be important in biofilm formation, can be used as a nutrient source, and could be involved in DNA damage repair and gene transfer. This review covers several aspects of eDNA research: (i) its occurrence and distribution in natural environments, (ii) the mechanisms and regulation of its release in cultured microorganisms, and (iii) its biological roles. In addition, we propose that eDNA release could be considered a social behavior, based on its quorum sensing-dependent regulation and on the described functions of eDNA in the context of microbial communities. PMID:28798731

Cultural differences in hedonic emotion regulation after a negative event.

PubMed

Miyamoto, Yuri; Ma, Xiaoming; Petermann, Amelia G

2014-08-01

Beliefs about emotions can influence how people regulate their emotions. The present research examined whether Eastern dialectical beliefs about negative emotions lead to cultural differences in how people regulate their emotions after experiencing a negative event. We hypothesized that, because of dialectical beliefs about negative emotions prevalent in Eastern culture, Easterners are less motivated than Westerners to engage in hedonic emotion regulation-up-regulation of positive emotions and down-regulation of negative emotions. By assessing online reactions to a recent negative event, Study 1 found that European Americans are more motivated to engage in hedonic emotion regulation. Furthermore, consistent with the reported motivation to regulate emotion hedonically, European Americans show a steeper decline in negative emotions 1 day later than do Asians. By examining retrospective memory of reactions to a past negative event, Study 2 further showed that cultural differences in hedonic emotion regulation are mediated by cultural differences in dialectical beliefs about motivational and cognitive utility of negative emotions, but not by personal deservingness or self-efficacy beliefs. These findings demonstrate the role of cultural beliefs in shaping emotion regulation and emotional experiences.

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies' professionals in the European Economic Area.

PubMed

WŁodarczak, Urszula; Swieczkowski, Damian; Religioni, Urszula; Jaguszewski, Milosz; Krysinski, Jerzy; Merks, Piotr

2017-01-01

The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively). Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient.

Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective.

PubMed

Cookson, Richard; Hutton, John

2003-02-01

Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. We identify five challenges for European policy-makers, and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are: (1). full publication of the economic evidence used in reimbursement decisions; (2). the redesign of licensing laws to improve the relevance of economic data available at product launch; (3). harmonisation of economic evaluation methodologies; (4). development of methodologies for evaluation of health inequality impacts; and (5). negotiation of price-performance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use.

The Modern University as an Imagined Community: European Dreams and Belarusian Realities

ERIC Educational Resources Information Center

Johnson, Mark S.; Tereshkovich, Pavel

2014-01-01

This article explores various aspects of modern Belarusian national identity through an analysis of two connected case studies, the development of the flagship national university, Belarusian State University (BSU) in Minsk and of the European Humanities University (EHU), a private institution founded in Minsk in 1992 with international funding.…

European distributed seismological data archives infrastructure: EIDA

NASA Astrophysics Data System (ADS)

Clinton, John; Hanka, Winfried; Mazza, Salvatore; Pederson, Helle; Sleeman, Reinoud; Stammler, Klaus; Strollo, Angelo

2014-05-01

The European Integrated waveform Data Archive (EIDA) is a distributed Data Center system within ORFEUS that (a) securely archives seismic waveform data and related metadata gathered by European research infrastructures, and (b) provides transparent access to the archives for the geosciences research communities. EIDA was founded in 2013 by ORFEUS Data Center, GFZ, RESIF, ETH, INGV and BGR to ensure sustainability of a distributed archive system and the implementation of standards (e.g. FDSN StationXML, FDSN webservices) and coordinate new developments. Under the mandate of the ORFEUS Board of Directors and Executive Committee the founding group is responsible for steering and maintaining the technical developments and organization of the European distributed seismic waveform data archive and the integration within broader multidisciplanry frameworks like EPOS. EIDA currently offers uniform data access to unrestricted data from 8 European archives (www.orfeus-eu.org/eida), linked by the Arclink protocol, hosting data from 75 permanent networks (1800+ stations) and 33 temporary networks (1200+) stations). Moreover, each archive may also provide unique, restricted datasets. A webinterface, developed at GFZ, offers interactive access to different catalogues (EMSC, GFZ, USGS) and EIDA waveform data. Clients and toolboxes like arclink_fetch and ObsPy can connect directly to any EIDA node to collect data. Current developments are directed to the implementation of quality parameters and strong motion parameters.

(Tenth symposium on microdosimetry, Rome, Italy; Department of Energy/Commission of European Communities workshop, Rome, Italy; and visit to Neuherberg, W. Germany, May 21--June 3, 1989): Foreign trip report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wright, H.A.

1989-06-15

Report of Harvel A. Wright, to participate in the Tenth Symposium on Microdosimetry in Rome, Italy, May 21-26, 1989; to participate in a Department of Energy/Commission of European Communities (DOE/CEC) Workshop on Long-Term Research Needs and Priorities in Microdosimetry, held in Rome following the microdosimetry symposium; and to visit the Gesellschaft fur Strahlen- and Umweltforschung (GSF) in Neuherberg, FRG, to carry out collaborative research with Dr. H.G. Paretzke.

European and German food legislation facing uncommon foodstuffs.

PubMed

Grabowski, Nils Th; Klein, Günter; López, Antonio Martínez

2013-01-01

In Europe, uncommon foodstuff (UFS, i.e., traditional foods from specific European regions and uncommon ethnic foods from non-EU countries) have been contributing to a diversification of the food supply. E-commerce and specialized retail shops are the main sources for UFS. This article discusses the legal bases for UFS introduction and evaluation. By means of 35 representative UFS, this article analyses the possibilities of trade and veterinary inspection of these products in Germany, comparing European Union and national food legislation with the many idiosyncrasies the UFS presents. Conservatory legislation bans the trade with endangered species (primates, cetaceans, songbirds), but for many other species, this is a complex matter that may ban only subpopulations from trade. Although introduction of legal UFS is regulated (yet complicated), the lack of appropriate definitions, intra-European trade harmonization, and of sufficient scientific knowledge hampers a satisfactory evaluation of many UFSs, for example, reptile meat or terrestrial insects. In these cases, official inspection would only be very basic.

Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

PubMed

Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

2011-03-01

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

First proficiency testing to evaluate the ability of European Union National Reference Laboratories to detect staphylococcal enterotoxins in milk products.

PubMed

Hennekinne, Jacques-Antoine; Gohier, Martine; Maire, Tiphaine; Lapeyre, Christiane; Lombard, Bertrand; Dragacci, Sylviane

2003-01-01

The European Commission has designed a network of European Union-National Reference Laboratories (EU-NRLs), coordinated by a Community Reference Laboratory (CRL), for control of hygiene of milk and milk products (Council Directive 92/46/ECC). As a common contaminant of milk and milk products such as cheese, staphylococcal enterotoxins are often involved in human outbreaks and should be monitored regularly. The main tasks of the EU-CRLs were to select and transfer to the EU-NRLs a reference method for detection of enterotoxins, and to set up proficiency testing to evaluate the competency of the European laboratory network. The first interlaboratory exercise was performed on samples of freeze-dried cheese inoculated with 2 levels of staphylococcal enterotoxins (0.1 and 0.25 ng/g) and on an uninoculated control. These levels were chosen considering the EU regulation for staphylococcal enterotoxins in milk and milk products and the limit of detection of the enzyme-linked immunosorbent assay test recommended in the reference method. The trial was conducted according to the recommendations of ISO Guide 43. Results produced by laboratories were compiled and compared through statistical analysis. Except for data from 2 laboratories for the uninoculated control and cheese inoculated at 0.1 ng/g, all laboratories produced satisfactory results, showing the ability of the EU-NRL network to monitor the enterotoxin contaminant.

Data Bases in Vocational Education and Training. The European Scene.

ERIC Educational Resources Information Center

European Centre for the Development of Vocational Training, Berlin (West Germany).

This study of public access databases in vocational education and training was conducted in the European Economic Community (EEC). Principal sources for the study were a survey sent to practitioners in eight countries; country studies on France, Greece, Italy, and the United Kingdom; and field work involving visits to Belgium, the Netherlands,…

European Mobile Satellite Services (EMSS): A regional system for Europe

NASA Technical Reports Server (NTRS)

Loisy, C.; Edin, P.; Benedicto, F. J.

1995-01-01

The European Space Agency is presently procuring two L-band payloads in order to promote a regional system for the provision of European Mobile Satellite Services (EMSS). These are the EMS payload on the Italsat I-F2 satellite and the LLM payload on the ARTEMIS satellite. Telecommunication system studies have been concentrating on mobile applications where full European geographical coverage is required. Potential applications include high priority Private Mobile Radio networks requiring national or European coverage, such as civil security, fire brigades, police and health services, as well as a dedicated system for provision of Air Traffic Services to the civil aviation community. A typical application is an intelligent road traffic management system combining a geographically selective traffic data collection service based on probe vehicles with a geographically selective traffic information broadcast service. Network architectures and bearer services have been developed both for data only and voice/data services. Vehicle mounted mobile transceivers using CDMA access techniques have been developed. The EMSS operational phase will start with the EMS payload in orbit in 1996 and continue with the LLM payload in 1997.

Is parallel trade in medicines compatible with the single European market?

PubMed

Senior, I

1992-01-01

For many years the varying methods of price control of medicines by national governments in the European Community (and elsewhere) have resulted in wide variations in prices. Parallel traders buy products in low pricing Community countries and sell them, generally relabelled or repackaged, in high pricing Community countries. This practice diverts sales revenue and profits from the manufacturers to the traders, distributors, pharmacists and, in some measure, to the sickness funds and to some patients. While parallel trade appeals to those who gain financially, its basis is a market distortion that poses a significant threat to the future of the research-based pharmaceutical industry.

Regulation of sporicides under the European Biocidal Products Directive.

PubMed

Low, A

2011-03-01

Disinfectants (including sporicides) used in the healthcare setting fall within the scope of the European Biocidal Products Directive (98/8/EC). The active substances used in these products will be evaluated as part of an EU wide review programme, to determine whether they can be used in biocidal products without undue risks to humans, animals and the environment, and that these products will be effective. Following the review of an active substance, biocidal products containing the active substance will become subject to regulatory controls in all EU Member States. This paper discusses how the Directive operates, both through the review programme and the authorisation of biocidal products at the Member State level, together with the requirements to provide data on the efficacy of both the active substances and end-use biocidal products. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

[Present regulation on infant and follow-on formula].

PubMed

Angulo Lucena, R; Gallego Domínguez, M C; Bentabol Manzanares, A; Jodral Villarejo, M

1995-01-01

The commercialization of breast milk substitutes has had great economic transcendence, sometimes without considering the sanitary and nutritional consequences for the customer. The sanitary authorities have been implied in this matter both in the International and European fields, issuing standards and regulations for the commercialization of breast milk substitutes which have been adopted by the Spanish Regulation. The aim of this paper is comment the regulations that affect foods for breast-feeding and short age children. This report analyzes and comments on the contents of international, european and national regulation on infant and follow-on formula. The regulations about Infant formula and Follow-on formula, banning the term of "humanized milk" and remarking the preference for breast feeding, which could only be substituted by sanitary professionals. This regulation deals with the appropriate chemical composition of these products, qualitative and quantitative. It includes standards for correct labeling, which should contain the appropriate information without idealizing the product Drawings and pictures showing the correct preparation are allowed. It provides for distribution and sales, as well as for correct advertising, which should be under control. This regulation also bans free samples and any other donation to particular customers or sanitary institutions. The present regulation on "Infant and Follow-on formulas" pursues the adequate nutrition of breast-feeding and short age children, being the protection of this kind of customers everyone's responsibility.

7 CFR 1942.17 - Community facilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 13 2010-01-01 2009-01-01 true Community facilities. 1942.17 Section 1942.17...) PROGRAM REGULATIONS (CONTINUED) ASSOCIATIONS Community Facility Loans § 1942.17 Community facilities. (a... successor agency under Public Law 103-354 policies and requirements pertaining to loans for community...

Migration in Afro-Brazilian rural communities: crossing demographic and genetic data.

PubMed

Amorim, Carlos Eduardo G; Gontijo, Carolina C; Falcão-Alencar, Gabriel; Godinho, Neide M O; Toledo, Rafaela C P; Pedrosa, Maria Angélica F; Luizon, Marcelo R; Simões, Aguinaldo L; Klautau-Guimãres, Maria N; Oliveira, Silviene F

2011-08-01

Many studies have used genetic markers to understand global migration patterns of our species. However, there are only few studies of human migration on a local scale. We, therefore, researched migration dynamics in three Afro-Brazilian rural communities, using demographic data and ten Ancestry Informative Markers. In addition to the description of migration and marriage structures, we carried out genetic comparisons between the three populations, as well as between locals and migrants from each community. Genetic admixture analyses were conducted according to the gene-identity method, with Sub-Saharan Africans, Amerindians, and Europeans as parental populations. The three analyzed Afro-Brazilian rural communities consisted of 16% to 30% of migrants, most of them women. The age pyramid revealed a gap in the segment of men aged between 20 to 30 yrs. While endogamous marriages predominated, exogamous marriages were mainly patrilocal. Migration dynamics are apparently associated with matrimonial customs and other social practices of such communities. The impact of migration upon the populations' genetic composition was low but showed an increase in European alleles with a concomitant decrease in the Amerindian contribution. Admixture analysis evidenced a higher African contribution to the gene pool of the studied populations, followed by the contribution of Europeans and Amerindians, respectively.

ALARA in European nuclear installations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lefaure, C.; Croft, J.; Pfeffer, W.

1995-03-01

For over a decade the Commission of the European Community has sponsored research projects on the development and practical implementation of the Optimization principle, or as it is often referred to, ALARA. These projects have given rise to a series of successful international Optimization training courses and have provided a significant input to the periodic European Seminars on Optimization, the last one of which took place in April 1993. This paper reviews the approaches to Optimization that have development within Europe and describes the areas of work in the current project. The on-going CEC research project addresses the problem ofmore » ALARA and internal exposures, and tries to define procedures for ALARA implementation, taking account of the perception of the hazard as well as the levels of probability of exposure. The relationships between ALARA and work management, and ALARA and decommissioning of installations appear to be other fruitful research areas. Finally, this paper introduces some software for using ALARA decision aiding techniques and databases containing feed back experience developed in Europe.« less

[The intervention of the immigration factor in Turco-European relations].

PubMed

Elmas, H B

1998-01-01

The legal dispositions governing Turkish immigration to European countries, the imperfect success of European efforts to discourage immigration, and factors in the elevated potential for continuing Turkish emigration are examined in this article. Turkey's 1963 5-year plan clearly revealed the government's intention to utilize external assistance to finance development efforts, while depending on labor migration to European countries to absorb surplus labor and provide remittances to ease the chronic balance of payments deficit. The Turkish government viewed with satisfaction the adoption in the 1963 Ankara Accord (a preliminary document in Turkey's quest for European Community membership) of articles concerning free circulation of workers, but the dispositions were never put into practice. The termination of immigration by the European countries in 1973-74 initially appeared to be a temporary response to the petroleum crisis and worldwide recession, but the measure became permanent policy, contributing to the deterioration of Turkish-European relations. Because of its internal policies of repression of minorities, sharp regional and ethnic disparities in development and income, and continuing high rate of population growth, Turkey has a very strong potential for further emigration. Some 4 million Turks constitute the largest foreign group in Europe. Immigration control measures have slowed entry of workers, but they have not prevented immigration for family regrouping or influx of refugees seeking asylum.

Scientific Issues Relevant to Setting Regulatory Criteria to Identify Endocrine-Disrupting Substances in the European Union.

PubMed

Slama, Rémy; Bourguignon, Jean-Pierre; Demeneix, Barbara; Ivell, Richard; Panzica, Giancarlo; Kortenkamp, Andreas; Zoeller, R Thomas

2016-10-01

Endocrine disruptors (EDs) are defined by the World Health Organization (WHO) as exogenous compounds or mixtures that alter function(s) of the endocrine system and consequently cause adverse effects in an intact organism, or its progeny, or (sub)populations. European regulations on pesticides, biocides, cosmetics, and industrial chemicals require the European Commission to establish scientific criteria to define EDs. We address the scientific relevance of four options for the identification of EDs proposed by the European Commission. Option 1, which does not define EDs and leads to using interim criteria unrelated to the WHO definition of EDs, is not relevant. Options 2 and 3 rely on the WHO definition of EDs, which is widely accepted by the scientific community, with option 3 introducing additional categories based on the strength of evidence (suspected EDs and endocrine-active substances). Option 4 adds potency to the WHO definition, as a decision criterion. We argue that potency is dependent on the adverse effect considered and is scientifically ambiguous, and note that potency is not used as a criterion to define other particularly hazardous substances such as carcinogens and reproductive toxicants. The use of potency requires a context that goes beyond hazard identification and corresponds to risk characterization, in which potency (or, more relevantly, the dose-response function) is combined with exposure levels. There is scientific agreement regarding the adequacy of the WHO definition of EDs. The potency concept is not relevant to the identification of particularly serious hazards such as EDs. As is common practice for carcinogens, mutagens, and reproductive toxicants, a multi-level classification of ED based on the WHO definition, and not considering potency, would be relevant (corresponding to option 3 proposed by the European Commission). Slama R, Bourguignon JP, Demeneix B, Ivell R, Panzica G, Kortenkamp A, Zoeller RT. 2016. Scientific issues relevant

Scientific Issues Relevant to Setting Regulatory Criteria to Identify Endocrine-Disrupting Substances in the European Union

PubMed Central

Slama, Rémy; Bourguignon, Jean-Pierre; Demeneix, Barbara; Ivell, Richard; Panzica, Giancarlo; Kortenkamp, Andreas; Zoeller, R. Thomas

2016-01-01

Background: Endocrine disruptors (EDs) are defined by the World Health Organization (WHO) as exogenous compounds or mixtures that alter function(s) of the endocrine system and consequently cause adverse effects in an intact organism, or its progeny, or (sub)populations. European regulations on pesticides, biocides, cosmetics, and industrial chemicals require the European Commission to establish scientific criteria to define EDs. Objectives: We address the scientific relevance of four options for the identification of EDs proposed by the European Commission. Discussion: Option 1, which does not define EDs and leads to using interim criteria unrelated to the WHO definition of EDs, is not relevant. Options 2 and 3 rely on the WHO definition of EDs, which is widely accepted by the scientific community, with option 3 introducing additional categories based on the strength of evidence (suspected EDs and endocrine-active substances). Option 4 adds potency to the WHO definition, as a decision criterion. We argue that potency is dependent on the adverse effect considered and is scientifically ambiguous, and note that potency is not used as a criterion to define other particularly hazardous substances such as carcinogens and reproductive toxicants. The use of potency requires a context that goes beyond hazard identification and corresponds to risk characterization, in which potency (or, more relevantly, the dose–response function) is combined with exposure levels. Conclusions: There is scientific agreement regarding the adequacy of the WHO definition of EDs. The potency concept is not relevant to the identification of particularly serious hazards such as EDs. As is common practice for carcinogens, mutagens, and reproductive toxicants, a multi-level classification of ED based on the WHO definition, and not considering potency, would be relevant (corresponding to option 3 proposed by the European Commission). Citation: Slama R, Bourguignon JP, Demeneix B, Ivell R, Panzica G

Call for a dedicated European legal framework for bacteriophage therapy.

PubMed

Verbeken, Gilbert; Pirnay, Jean-Paul; Lavigne, Rob; Jennes, Serge; De Vos, Daniel; Casteels, Minne; Huys, Isabelle

2014-04-01

The worldwide emergence of antibiotic resistances and the drying up of the antibiotic pipeline have spurred a search for alternative or complementary antibacterial therapies. Bacteriophages are bacterial viruses that have been used for almost a century to combat bacterial infections, particularly in Poland and the former Soviet Union. The antibiotic crisis has triggered a renewed clinical and agricultural interest in bacteriophages. This, combined with new scientific insights, has pushed bacteriophages to the forefront of the search for new approaches to fighting bacterial infections. But before bacteriophage therapy can be introduced into clinical practice in the European Union, several challenges must be overcome. One of these is the conceptualization and classification of bacteriophage therapy itself and the extent to which it constitutes a human medicinal product regulated under the European Human Code for Medicines (Directive 2001/83/EC). Can therapeutic products containing natural bacteriophages be categorized under the current European regulatory framework, or should this framework be adapted? Various actors in the field have discussed the need for an adapted (or entirely new) regulatory framework for the reintroduction of bacteriophage therapy in Europe. This led to the identification of several characteristics specific to natural bacteriophages that should be taken into consideration by regulators when evaluating bacteriophage therapy. One important consideration is whether bacteriophage therapy development occurs on an industrial scale or a hospital-based, patient-specific scale. More suitable regulatory standards may create opportunities to improve insights into this promising therapeutic approach. In light of this, we argue for the creation of a new, dedicated European regulatory framework for bacteriophage therapy.

The European Union Response to Regional Conflicts

DTIC Science & Technology

2013-03-01

into force of the Lisbon Treaty. (Cuadernos de Estrategia , 145-B. Spanish Institute for Strategic Studies, 2010), 18. 4 Felix Arteaga, The European...Security and Defense Policy after the entry into force of the Lisbon Treaty. (Cuadernos de Estrategia , 145-B. Spanish Institute for Strategic...Lisbon Treaty. (Cuadernos de Estrategia , 145-B. Spanish Institute for Strategic Studies. 2010), 37. 15 ENP regulates the EU’s relations with countries

Aflatoxin Regulations in a Network of Global Maize Trade

PubMed Central

Wu, Felicia; Guclu, Hasan

2012-01-01

Worldwide, food supplies often contain unavoidable contaminants, many of which adversely affect health and hence are subject to regulations of maximum tolerable levels in food. These regulations differ from nation to nation, and may affect patterns of food trade. We soughtto determine whether there is an association between nations' food safety regulations and global food trade patterns, with implications for public health and policymaking. We developed a network model of maize trade around the world. From maize import/export data for 217 nations from 2000–2009, we calculated basic statistics on volumes of trade; then examined how regulations of aflatoxin, a common contaminant of maize, are similar or different between pairs of nations engaging in significant amounts of maize trade. Globally, market segregation appears to occur among clusters of nations. The United States is at the center of one cluster; European countries make up another cluster with hardly any maize trade with the US; and Argentina, Brazil, and China export maize all over the world. Pairs of nations trading large amounts of maize have very similar aflatoxin regulations: nations with strict standards tend to trade maize with each other, while nations with more relaxed standards tend to trade maize with each other. Rarely among the top pairs of maize-trading nations do total aflatoxin standards (standards based on the sum of the levels of aflatoxins B1, B2, G1, and G2) differ by more than 5 µg/kg. These results suggest that, globally, separate maize trading communities emerge; and nations tend to trade with other nations that have very similar food safety standards. PMID:23049773

The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans.

PubMed

Wimmer, Stefan; Rascher, Wolfgang; McCarthy, Suzanne; Neubert, Antje

2014-10-01

Prior to the implementation of the EU Paediatric Regulation, the European Medicines Agency (EMA) defined unmet paediatric needs for active substances already available on the market. Seven years after the Paediatric Regulation came into force, we investigated the extent to which previously identified needs have led to programmes for generating evidence necessary for the regulatory approval of medicines for managing childhood conditions. The websites of the EMA and the European Commission Community Research and Development Information Service (CORDIS) were systematically screened to identify active substances from the assessment of paediatric needs, off-patent priority list, agreed Paediatric Investigation Plans (PIP) and 7th Framework Programme (FP7) projects related to paediatric medicines. A total of 357 active substances with paediatric needs were identified by June 2013. 511 PIPs were agreed by the Paediatric Committee at the EMA (PDCO), including 51 (14.3 %) PIPs for a previously identified need. Amongst those, 21 were off-patent at the time of the PIP approval, 15 of which received funding from the European Commission's FP7. According to the assessment of paediatric needs, evidence is particularly needed for active substances treating cardiovascular diseases (n = 61), cancer (n = 40) and in the field of anaesthesiology (n = 38). Whereas oncology drugs (n = 66) were frequently represented in PIPs, drugs for cardiovascular diseases (n = 39) and anaesthesiology (n = 3) rarely were. Most PIPs are attributable to marketing authorisations of new active substances, whereas off-patent drugs which are commonly used off-label remain unstudied to a large extent. More effort including ongoing research funding is essential to further regularise and standardise paediatric pharmacotherapy.

Astrobiology Road Mapping (AstRoMap) - A project within FP7 of the European Commission: First results

NASA Astrophysics Data System (ADS)

Gomez-Gomez, Felipe; Capria, Maria Teresa; Palomba, Ernesto; Walter, Nicolas; Rettberg, Petra; Muller, Christian; Horneck, Gerda

AstRoMap (Astrobiology and Planetary Exploration Road Mapping) is a funded project formulated in the 5th Call of the European Commission FP7 framework. The main objectives of the AstRoMap are: 1. Identify the main astrobiology issues to be addressed by Europe in the next decades in relation with space exploration 2. Identify potential mission concepts that would allow addressing these issues 3. Identify the technology developments required to enable these missions 4. Provide a prioritized roadmap integrating science and technology activities as well as ground-based approach 5. Map scientific knowledge related to astrobiology in Europe To reach those objectives, AstRoMap is executed within the following steps: 1. Community consultation. In order to map the European astrobiology landscape and to provide a collaborative networking platform for this community, the AstRoMap project hosts a database of scientists (European and beyond) interested in astrobiology and planetary exploration (see: http://www.astromap.eu/database.html). It reflects the demography and the research and teaching activities of the astrobiology community, as well as their professional profiles and involvement in astrobiology projects. Considering future aspects of astrobiology in Europe, the need for more astrobiology-dedicated funding programmes at the EU level, especially for cross-disciplinary groups, was stressed. This might eventually lead to the creation of a European laboratory of Astrobiology, or even of a European Astrobiology Institute. 2. Workshops organisation. On the basis of the feedbacks from the community consultation, the potential participants and interesting topics are being identified to take part in the following workshops: 1-. Origin of organic compounds, steps to life; 2. Physico-chemical boundary conditions for habitability 3. Biosignatures as facilitating life detection 4. Origin of the Solar system 3. Astrobiology road-mapping. Based on the results and major conclusions

Synthetic biology in the view of European public funding organisations

PubMed Central

Pei, Lei; Gaisser, Sibylle; Schmidt, Markus

2012-01-01

We analysed the decisions of major European public funding organisations to fund or not to fund synthetic biology (SB) and related ethical, legal and social implication (ELSI) studies. We investigated the reaction of public organisations in six countries (Austria, France, Germany, the Netherlands, Switzerland and the UK) towards SB that may influence SB’s further development in Europe. We examined R&D and ELSI communities and their particular funding situation. Our results show that the funding situation for SB varies considerably among the analysed countries, with the UK as the only country with an established funding scheme for R&D and ELSI that successfully integrates these research communities. Elsewhere, we determined a general lack of funding (France), difficulties in funding ELSI work (Switzerland), lack of an R&D community (Austria), too small ELSI communities (France, Switzerland, Netherlands), or difficulties in linking existing communities with available funding sources (Germany), partly due to an unclear SB definition. PMID:22586841

Synthetic biology in the view of European public funding organisations.

PubMed

Pei, Lei; Gaisser, Sibylle; Schmidt, Markus

2012-02-01

We analysed the decisions of major European public funding organisations to fund or not to fund synthetic biology (SB) and related ethical, legal and social implication (ELSI) studies. We investigated the reaction of public organisations in six countries (Austria, France, Germany, the Netherlands, Switzerland and the U.K.) towards SB that may influence SB's further development in Europe. We examined R&D and ELSI communities and their particular funding situation. Our results show that the funding situation for SB varies considerably among the analysed countries, with the U.K. as the only country with an established funding scheme for R&D and ELSI that successfully integrates these research communities. Elsewhere, we determined a general lack of funding (France), difficulties in funding ELSI work (Switzerland), lack of an R&D community (Austria), too small ELSI communities (France, Switzerland, Netherlands), or difficulties in linking existing communities with available funding sources (Germany), partly due to an unclear SB definition.

Albania’s Road Toward Integrated and Accession into the European Union

DTIC Science & Technology

2014-06-13

50 vii Regional issues and international obligations ........................................................51...88 viii ACRONYMS AI Amnesty International APL Albanian Party of Labor CARDS Community Assistance for Reconstruction, Development...IMF International Monetary Fund IPA Instrument for Pre-accession assistance MEI Ministry of European Integration MFA Ministry of Foreign Affairs

Report of the Second European Zebrafish Principal Investigator Meeting in Karlsruhe, Germany, March 21-24, 2012.

PubMed

Cavodeassi, Florencia; Del Bene, Filippo; Fürthauer, Maximilian; Grabher, Clemens; Herzog, Wiebke; Lehtonen, Sanna; Linker, Claudia; Mercader, Nadia; Mikut, Ralf; Norton, William; Strähle, Uwe; Tiso, Natascia; Foulkes, Nicholas S

2013-03-01

The second European Zebrafish Principal Investigator (PI) Meeting was held in March, 2012, in Karlsruhe, Germany. It brought together PIs from all over Europe who work with fish models such as zebrafish and medaka to discuss their latest results, as well as to resolve strategic issues faced by this research community. Scientific discussion ranged from the development of new technologies for working with fish models to progress in various fields of research such as injury and repair, disease models, and cell polarity and dynamics. This meeting also marked the establishment of the European Zebrafish Resource Centre (EZRC) at Karlsruhe that in the future will serve as an important focus and community resource for zebrafish- and medaka-based research.

Risk assessment of nanomaterials in cosmetics: a European union perspective.

PubMed

Henkler, Frank; Tralau, Tewes; Tentschert, Jutta; Kneuer, Carsten; Haase, Andrea; Platzek, Thomas; Luch, Andreas; Götz, Mario E

2012-11-01

In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF ; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm ). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP's 'Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation' (The SCCP's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf ), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html ). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31

Cuticles of European and American lobsters harbor diverse bacterial species and differ in disease susceptibility.

PubMed

Whitten, Miranda M A; Davies, Charlotte E; Kim, Anita; Tlusty, Michael; Wootton, Emma C; Chistoserdov, Andrei; Rowley, Andrew F

2014-06-01

Diseases of lobster shells have a significant impact on fishing industries but the risk of disease transmission between different lobster species has yet to be properly investigated. This study compared bacterial biofilm communities from American (Homarus americanus) and European lobsters (H. gammarus), to assess both healthy cuticle and diseased cuticle during lesion formation. Culture-independent molecular techniques revealed diversity in the bacterial communities of cuticle biofilms both within and between the two lobster species, and identified three bacterial genera associated with shell lesions plus two putative beneficial bacterial species (detected exclusively in healthy cuticle or healing damaged cuticle). In an experimental aquarium shared between American and European lobsters, heterospecific transmission of potentially pathogenic bacteria appeared to be very limited; however, the claws of European lobsters were more likely to develop lesions when reared in the presence of American lobsters. Aquarium biofilms were also examined but revealed no candidate pathogens for environmental transmission. Aquimarina sp. 'homaria' (a potential pathogen associated with a severe epizootic form of shell disease) was detected at a much higher prevalence among American than European lobsters, but its presence correlated more with exacerbation of existing lesions rather than with lesion initiation. © 2014 The Authors. MicrobiologyOpen published by John Wiley & Sons Ltd.

Multi-scale variation in spatial heterogeneity for microbial community structure in an eastern Virginia agricultural field

NASA Technical Reports Server (NTRS)

Franklin, Rima B.; Mills, Aaron L.

2003-01-01

To better understand the distribution of soil microbial communities at multiple spatial scales, a survey was conducted to examine the spatial organization of community structure in a wheat field in eastern Virginia (USA). Nearly 200 soil samples were collected at a variety of separation distances ranging from 2.5 cm to 11 m. Whole-community DNA was extracted from each sample, and community structure was compared using amplified fragment length polymorphism (AFLP) DNA fingerprinting. Relative similarity was calculated between each pair of samples and compared using geostatistical variogram analysis to study autocorrelation as a function of separation distance. Spatial autocorrelation was found at scales ranging from 30 cm to more than 6 m, depending on the sampling extent considered. In some locations, up to four different correlation length scales were detected. The presence of nested scales of variability suggests that the environmental factors regulating the development of the communities in this soil may operate at different scales. Kriging was used to generate maps of the spatial organization of communities across the plot, and the results demonstrated that bacterial distributions can be highly structured, even within a habitat that appears relatively homogeneous at the plot and field scale. Different subsets of the microbial community were distributed differently across the plot, and this is thought to be due to the variable response of individual populations to spatial heterogeneity associated with soil properties. c2003 Federation of European Microbiological Societies. Published by Elsevier Science B.V. All rights reserved.

Policies and availability of orphan medicines in outpatient care in 24 European countries.

PubMed

Sarnola, Kati; Ahonen, Riitta; Martikainen, Jaana E; Timonen, Johanna

2018-04-09

To assess pricing and reimbursement policies specific to orphan medicines and the availability and distribution settings of ten recently authorised medicinal products suitable for outpatient care with orphan status and centralised marketing authorisation in Europe, and whether patients receive these products free of charge or have to pay some or all of the costs themselves. Web survey to authorities and representatives of third party payers in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in April 2016. In most of the 24 countries, special policies were not implemented in the assessment of reimbursement status (22 countries) or in the pricing (20 countries) of orphan medicines. An average of five of the ten recently authorised products per country were available for outpatient care. Products were dispensed from community pharmacies in eight countries and from health care units in five countries. In four countries, both distribution settings were used. When products were dispensed from community pharmacies, patients typically paid some of the price themselves. Products dispensed from health care units were often free of charge for patients. Most European countries had not implemented pricing and reimbursement policies specific to orphan medicines. The availability of orphan products varied between countries. It is important to discuss whether orphan medicines should be considered as a separate group in the reimbursement regulations in order to secure patient access to these medicines.

Effects of diesel/biodiesel blends on regulated and unregulated pollutants from a passenger vehicle operated over the European and the Athens driving cycles

NASA Astrophysics Data System (ADS)

Karavalakis, George; Stournas, Stamoulis; Bakeas, Evangelos

This paper presents the regulated and unregulated exhaust emissions of a diesel passenger vehicle, operated with low sulphur automotive diesel and soy methyl ester blends. Emission and fuel consumption measurements were conducted under real driving conditions (Athens Driving Cycle, ADC) and compared with those of a modified New European Driving Cycle (NEDC) using a chassis dynamometer. A Euro II compliant diesel vehicle was used in this study, equipped with an indirect injection diesel engine, fuelled with diesel fuel and biodiesel blends at proportions of 5, 10, and 20% respectively. Unregulated emissions of 11 polycyclic aromatic hydrocarbons (PAHs), 5 nitro-PAHs, 13 carbonyl compounds (CBCs) and the soluble organic fraction (SOF) of the particulate matter were measured. Qualitative hydrocarbon analysis was also performed on the SOF. Regulated emissions of NO x, CO, HC, CO 2, and PM were also measured over the two test cycles. It was established that some of the emissions measured over the (hot-start) NEDC differed from the real-world cycle. Significant differences were also observed in the vehicle's fuel consumption between the two test cycles. The addition of biodiesel reduced the regulated emissions of CO, HC and PM, while an increase in NO x was observed over the ADC. Carbonyl emissions, PAHs and nitro-PAHs were reduced with the addition of biodiesel over both driving cycles.

Food additives used in meat processing according to the Polish and European Union legislation.

PubMed

Uradziński, J; Weiner, M

2003-01-01

This paper presents the legal regulations related to the use of food additives in meat production in Poland and the European Union. The Polish legal definition of food additives is given as well as the classification of permitted food additives added to food and stimulants by their technological function. In addition, a definition of processing aids in the food industry is included. It shows that Polish legislation includes food additives used to ensure or improve food nutritional value, whereas in the EU legislation, these substances are not included in the list of food additives. Moreover, the Council Directives include food additive specific purity criteria, whereas the Polish regulations do not mention the legal regulations of this issue in practice. The European Union use mechanisms and procedures for the introduction of new food additives into internal markets as well as controlling the circulation of additives. The Polish legislation in practice, however, does not determine approval or methods for the introduction of new food additives to the market. Legal regulations on the monitoring of food additives no exist.

Building a Just Adolescent Community

ERIC Educational Resources Information Center

Enright, Mary Schaefer; Schaefer, Lawrence V.; Schaefer, Patricia S.; Schaefer, Kristin A.

2008-01-01

Lawrence Kohlberg, a psychologist, coined the term "Just Community" to describe a community built on trust and resolution, in which each member participates democratically in the development of the rules and regulations that govern their community life (Kohlberg, 1985). In a school, this means that students and teachers alike actively participate…

Discounts and rebates granted to public payers for medicines in European countries

PubMed Central

Vogler, Sabine; Zimmermann, Nina; Habl, Claudia; Piessnegger, Jutta; Bucsics, Anna

2012-01-01

Objective: The objective of this study was to provide an overview about the existence and types of discounts and rebates granted to public payers by the pharmaceutical industry in European countries. Methods: Data were collected via a questionnaire in spring 2011. Officials from public authorities for pharmaceutical pricing and reimbursement represented in the PPRI (Pharmaceutical Pricing and Reimbursement Information) network provided the information and reviewed the compilation. Results: Information is available from 31 European countries. Discounts and rebates granted to public payers by pharmaceutical industry were reported for 25 European countries. Such discounts exist both in the in- and out-patient sectors in 21 countries and in the in-patient sector only in four countries. Six countries reported not having any regulations or agreements regarding the discounts and rebates granted by industry. The most common discounts and rebates are price reductions and refunds linked to sales volume but types such as in-kind support, price-volume and risk-sharing agreements are also in place. A mix of various types of discounts and rebates is common. Many of these arrangements are confidential. Differences regarding types, the organizational and legal framework, validity and frequency of updates and the amount of the discounts and rebates granted exist among the surveyed countries. Conclusions: In Europe, discounts and rebates on medicines granted by pharmaceutical industry to public payers are common tools to contain public pharmaceutical expenditure. They appear to be used as a complimentary measure when price regulation does not achieve the desired results and in the few European countries with no or limited price regulation. The confidential character of many of these arrangements impedes transparency and may lead to a distortion of medicines prices. An analysis of the impact on these measures is recommended. PMID:23093898

A Community-University Exchange Project Modeled after Europe's Science Shops

ERIC Educational Resources Information Center

Tryon, Elizabeth; Ross, J. Ashleigh

2012-01-01

This article describes a pilot project of the Morgridge Center for Public Service at the University of Wisconsin-Madison for a new structure for community-based learning and research. It is based on the European-derived science shop model for democratizing campus-community partnerships using shared values of mutual respect and validation of…

European Gravity Service for Improved Emergency Management - Status and project highlights

NASA Astrophysics Data System (ADS)

Mayer-Guerr, Torsten; Adrian, Jäggi; Meyer, Ulrich; Jean, Yoomin; Susnik, Andreja; Weigelt, Matthias; van Dam, Tonie; Flechtner, Frank; Gruber, Christian; Güntner, Andreas; Gouweleeuw, Ben; Kvas, Andreas; Klinger, Beate; Flury, Jakob; Bruinsma, Sean; Lemoine, Jean-Michel; Zwenzner, Hendrik; Bourgogne, Stephane; Bandikova, Tamara

2016-04-01

The European Gravity Service for Improved Emergency Management (EGSIEM) is a project of the Horizon 2020 Framework Programme for Research and Innovation of the European Commission. EGSIEM shall demonstrate that observations of the redistribution of water and ice mass derived from the current GRACE mission, the future GRACE-FO mission, and additional data provide critical and complementary information to more traditional Earth Observation products and open the door for innovative approaches to flood and drought monitoring and forecasting. In the frame of EGSIEM three key services should established: 1) a scientific combination service to deliver the best gravity products for applications in Earth and environmental science research based on the unified knowledge of the European GRACE community, 2) a near real-time and regional service to reduce the latency and increase the temporal resolution of the mass redistribution products, and 3) a hydrological and early warning service to develop gravity-based indicators for extreme hydrological events and to demonstrate their value for flood and drought forecasting and monitoring services. All of these services shall be tailored to the various needs of the respective communities. Significant efforts shall also be devoted to transform the service products into user-friendly and easy-to-interpret data sets and the development of visualization tools. In this talk the status of the ongoing project is presented and selected results are discussed.

[The aims of German medical anthropology in countries of the European Community].

PubMed

Sterly, J

1992-07-01

Medical Anthropology deals with the anthropological conditions of health, illness and health care in different societies and cultures, and has to be distinguished in that respect from Social and Industrial Medicine in German language countries which could be considered a kind of official and governmental medicine. While in North America Medical Anthropology has been established at nearly all universities and medical colleges during the last 25 years, corresponding activities in Germany and most other European countries have not reached university level up to now. After referring to general anthropology during the period of enlightenment and to philosophical and medical anthropology in the first half of our century, both to be considered forerunners of medical anthropology in german-speaking countries, an outline of medical anthropology in German-speaking countries, an outline of medical anthropology in the USA is given followed by a survey of questions and problems with which medical anthropology in German-speaking and other European countries has to cope, and would be confronted after the opening of the EC Market in 1993. The article concludes by briefly going into the circumstance of teaching medical anthropology in the Federal Republic of Germany.

78 FR 2319 - Relocation of Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... (CFR). The regulations relate to: Community Investment Cash Advance Programs (CICA); Federal Home Loan... (Community Investment Cash Advance Programs) In 1989, Congress amended the Federal Home Loan Bank Act (Bank Act) to authorize the Banks to offer Community Investment Cash Advance (CICA) programs, and to require...

Status of the European Atlas of Natural Radiation.

PubMed

Bossew, P; Tollefsen, T; Cinelli, G; Gruber, V; De Cort, M

2015-11-01

According to the EURATOM (European Atomic Energy Community) Treaty, one of the missions of the Joint Research Centre (JRC) of the European Commission (EC) is to collect, process, evaluate and present data on environmental radioactivity. In 2006, the JRC started the 'European Atlas of Natural Radiation' project, in order to give an overview of the geographic distribution of sources of, and exposures to, natural radiation. As a first task, a map of indoor radon concentration was created, because in most cases this is the most important contribution to exposure, and since it could be expected that data collection would take quite some time, because radon (Rn) surveys are very differently advanced between European countries. The authors show the latest status of this map. A technically more ambitious map proved the one of the geogenic Rn potential (RP), due to heterogeneity of data sources across Europe and the need to develop models to estimate a harmonised quantity which adequately measures or classifies the RP. Further maps currently in the making include those of secondary cosmic radiation, of terrestrial gamma radiation and of the concentrations of the elements U, Th and K that are its source. In this article, the authors show the progress of some of these maps. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

COBA-Cohort: a prospective cohort of HIV-negative men who have sex with men, attending community-based HIV testing services in five European countries (a study protocol).

PubMed

Lorente, Nicolas; Fernàndez-López, Laura; Fuertes, Ricardo; Rojas Castro, Daniela; Pichon, François; Cigan, Bojan; Chanos, Sophocles; Meireles, Paula; Lucas, Raquel; Morel, Stéphane; Slaaen Kaye, Per; Agustí, Cristina; Klavs, Irena; Platteau, Tom; Casabona, Jordi

2016-07-13

Community-based voluntary counselling and testing (CBVCT) services for men who have sex with men (MSM) can reach those most-at-risk and provide an environment for gay men that is likely to be non-stigmatising. Longitudinal data on the behaviour of HIV-negative MSM are scarce in Europe. The aim of this protocol, developed during the Euro HIV Early Diagnosis And Treatment (EDAT) project, is to implement a multicentre community-based cohort of HIV-negative MSM attending 15 CBVCT services in 5 European countries. (1) To describe the patterns of CBVCT use, (2) to estimate HIV incidence, and to identify determinants of (3) HIV seroconversion and (4) HIV and/or sexually transmitted infection (STI) test-seeking behaviour. All MSM aged 18 years or over and who had a negative HIV test result are invited to participate in the COmmunity-BAsed Cohort (COBA-Cohort). Study enrolment started in February 2015, and is due to continue for at least 12 months at each study site. Follow-up frequency depends on the testing recommendations in each country (at least 1 test per year). Sociodemographic data are collected at baseline; baseline and follow-up questionnaires both gather data on attitudes and perceptions, discrimination, HIV/STI testing history, sexual behaviour, condom use, and pre- and post-exposure prophylaxis. Descriptive, exploratory and multivariate analyses will be performed to address the main research objectives of this study, using appropriate statistical tests and models. These analyses will be performed on the whole cohort data and stratified by study site or country. The study was approved by the Public Health authorities of each country where the study is being implemented. Findings from the COBA-Cohort study will be summarised in a report to the European Commission, and in leaflets to be distributed to study participants. Articles and conference abstracts will be submitted to peer-reviewed journals and conferences. Published by the BMJ Publishing Group Limited

75 FR 69080 - Federal Travel Regulation (FTR)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... GENERAL SERVICES ADMINISTRATION Federal Travel Regulation (FTR) Fly America Act; United States and European Union ``Open Skies'' Air Transport Agreement (US-EU Open Skies Agreement) AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). [[Page 69081

European Paediatric Formulation Initiative (EuPFI)-Formulating Ideas for Better Medicines for Children.

PubMed

Salunke, Smita; Liu, Fang; Batchelor, Hannah; Walsh, Jenny; Turner, Roy; Ju, Tzuchi Rob; Tuleu, Catherine

2017-02-01

The European Paediatric Formulation Initiative (EuPFI), founded in 2007, aims to promote and facilitate the preparation of better and safe medicines for children through linking research and information dissemination. It brings together the capabilities of the industry, academics, hospitals, and regulators within a common platform in order to scope the solid understanding of the major issues, which will underpin the progress towards the future of paediatric medicines we want.The EuPFI was formed in parallel to the adoption of regulations within the EU and USA and has served as a community that drives research and dissemination through publications and the organisation of annual conferences. The membership and reach of this group have grown since its inception in 2007 and continue to develop and evolve to meet the continuing needs and ambitions of research into and development of age appropriate medicines. Five diverse workstreams (age-appropriate medicines, Biopharmaceutics, Administration Devices, Excipients and Taste Assessment & Taste Masking (TATM)) direct specific workpackages on behalf of the EuPFI. Furthermore, EuPFI interacts with multiple diverse professional groups across the globe to ensure efficient working in the area of paediatric medicines. Strong commitment and active involvement of all EuPFI stakeholders have proved to be vital to effectively address knowledge gaps related to paediatric medicines, discuss potential areas for further research and identify issues that need more attention and analysis in the future.

Considerations of nano-QSAR/QSPR models for nanopesticide risk assessment within the European legislative framework.

PubMed

Villaverde, Juan José; Sevilla-Morán, Beatriz; López-Goti, Carmen; Alonso-Prados, José Luis; Sandín-España, Pilar

2018-09-01

The European market for pesticides is currently legislated through the well-developed Regulation (EC) No. 1107/2009. This regulation promotes the competitiveness of European agriculture, recognizing the necessity of safe pesticides for human and animal health and the environment to protect crops against pests, diseases and weeds. In this sense, nanotechnology can provide a tremendous opportunity to achieve a more rational use of pesticides. However, the lack of information regarding nanopesticides and their fate and behavior in the environment and their effects on human and animal health is inhibiting rapid nanopesticide incorporation into European Union agriculture. This review analyzes the recent state of knowledge on nanopesticide risk assessment, highlighting the challenges that need to be overcame to accelerate the arrival of these new tools for plant protection to European agricultural professionals. Novel nano-Quantitative Structure-Activity/Structure-Property Relationship (nano-QSAR/QSPR) tools for risk assessment are analyzed, including modeling methods and validation procedures towards the potential of these computational instruments to meet the current requirements for authorization of nanoformulations. Future trends on these issues, of pressing importance within the context of the current European pesticide legislative framework, are also discussed. Standard protocols to make high-quality and well-described datasets for the series of related but differently sized nanoparticles/nanopesticides are required. Copyright © 2018 Elsevier B.V. All rights reserved.

Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

PubMed

Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

2018-06-01

The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

European views on controlling acid rain. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fay, J.A.

The National Governors Association (NGA) will be considering a plan for alleviating acid rain effects by reduction of emissions of sulfur and nitrogen oxides. This plan, in some respects similar to current legislative proposals in Congress, was formulated by the northeastern governors with administrative support from the Commonwealth of Massachusetts. Lt. Governor John Kerry has undertaken to prepare this plan for consideration by the NGA. In order to provide a better understanding of how other industrialized nations are dealing with the acid rain problem, the office of Lt. Gov. Kerry arranged for a tour of European countries during the weekmore » beginning 10 January 1984. Norway, Sweden, the Federal Republic of Germany (FRG), Belgium and the United Kingdom (UK) were visited, as well as the Commission of the European Communities (EEC) in Brussels.« less

Ectomycorrhizal-dominated boreal and tropical forests have distinct fungal communities, but analogous spatial patterns across soil horizons.

PubMed

McGuire, Krista L; Allison, Steven D; Fierer, Noah; Treseder, Kathleen K

2013-01-01

Fungi regulate key nutrient cycling processes in many forest ecosystems, but their diversity and distribution within and across ecosystems are poorly understood. Here, we examine the spatial distribution of fungi across a boreal and tropical ecosystem, focusing on ectomycorrhizal fungi. We analyzed fungal community composition across litter (organic horizons) and underlying soil horizons (0-20 cm) using 454 pyrosequencing and clone library sequencing. In both forests, we found significant clustering of fungal communities by site and soil horizons with analogous patterns detected by both sequencing technologies. Free-living saprotrophic fungi dominated the recently-shed leaf litter and ectomycorrhizal fungi dominated the underlying soil horizons. This vertical pattern of fungal segregation has also been found in temperate and European boreal forests, suggesting that these results apply broadly to ectomycorrhizal-dominated systems, including tropical rain forests. Since ectomycorrhizal and free-living saprotrophic fungi have different influences on soil carbon and nitrogen dynamics, information on the spatial distribution of these functional groups will improve our understanding of forest nutrient cycling.

Addiction research centres and the nurturing of creativity. Monitoring the European drug situation: the ongoing challenge for the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

PubMed

Griffiths, Paul; Mounteney, Jane; Lopez, Dominique; Zobel, Frank; Götz, Wolfgang

2012-02-01

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the designated hub for drug-related information in the European Union. The organization's role is to provide the European Union (EU) and its Member States with a factual overview of European drug problems and a common information framework to support the drugs debate. In order to achieve its mission, the EMCDDA coordinates and relies on a network of 30 national monitoring centres, the Reitox National Focal Points. The Centre publishes on a wide range of drug-related topics, across epidemiology, interventions, laws and policies. Every November, the EMCDDA publishes its Annual Report, providing a yearly update on the European drug situation, translated into 23 EU languages. In line with its founding regulation, the EMCDDA has a role acting as an interface between the worlds of science and policy. While not a research centre in the formal sense, the results the Centre generates serve as catalysts for new research questions and help to identify priorities. Current challenges facing the agency include continuing to increase scientific standards while maintaining a strong institutional role, as well as supporting European efforts to identify, share and codify best practice in the drugs field. © 2011 EMCDDA.

Vegetation community change points suggest that critical loads of nutrient nitrogen may be too high

NASA Astrophysics Data System (ADS)

Wilkins, Kayla; Aherne, Julian; Bleasdale, Andy

2016-12-01

It is widely accepted that elevated nitrogen deposition can have detrimental effects on semi-natural ecosystems, including changes to plant diversity. Empirical critical loads of nutrient nitrogen have been recommended to protect many sensitive European habitats from significant harmful effects. In this study, we used Threshold Indicator Taxa Analysis (TITAN) to investigate shifts in vegetation communities along an atmospheric nitrogen deposition gradient for twenty-two semi-natural habitat types (as described under Annex I of the European Union Habitats Directive) in Ireland. Significant changes in vegetation community, i.e., change points, were determined for twelve habitats, with seven habitats showing a decrease in the number of positive indicator species. Community-level change points indicated a decrease in species abundance along a nitrogen deposition gradient ranging from 3.9 to 15.3 kg N ha-1 yr-1, which were significantly lower than recommended critical loads (Wilcoxon signed-rank test; V = 6, p < 0.05). These results suggest that lower critical loads of empirical nutrient nitrogen deposition may be required to protect many European habitats. Changes to vegetation communities may mean a loss of sensitive indicator species and potentially rare species in these habitats, highlighting how emission reductions policies set under the National Emissions Ceilings Directive may be directly linked to meeting the goal set out under the European Union's Biodiversity Strategy of "halting the loss of biodiversity" across Europe by 2020.

Classification and management of asbestos-containing waste: European legislation and the Italian experience.

PubMed

Paglietti, Federica; Malinconico, Sergio; della Staffa, Beatrice Conestabile; Bellagamba, Sergio; De Simone, Paolo

2016-04-01

Production of a new classification of Asbestos Containing Products (ACPs), materials (ACM) and Asbestos Containing Waste (ACW), in addition to a correct identification of landfills where ACW should be disposed of in Europe. Analysis of the European and Italian legislation, study of waste classification and management in the main European countries, data analysis of mapping of Italian landfills and quantification of ACW disposed there. Classification according to unique criteria (physical state, substances with which asbestos minerals have been blended, function of the asbestos, etc.). Highlights of cases of incorrect management of ACW in Europe, specifying the Italian ones. Considering the significant inconsistencies between the European and national regulations and the actual implementation of those regulations, this paper provide some precise indications for the proper assignment to ACW of the European Waste Catalogue (EWC) codes. Lastly, suitable types of landfills at which ACW should be disposed of have been identified, in order to assisting the persons involved in ACW management to avoid undue exposition and their improper disposal. This study reports a useful manual for classifying worldwide ACPs based on their physical state and considering the substances with which the asbestos minerals have been blended. Moreover several clear tables allow the asbestos remediation and waste management operators to suitably classify and dispose of ACW. Copyright © 2016 Elsevier Ltd. All rights reserved.

Association between stricter alcohol advertising regulations and lower hazardous drinking across European countries.

PubMed

Bosque-Prous, Marina; Espelt, Albert; Guitart, Anna M; Bartroli, Montserrat; Villalbí, Joan R; Brugal, M Teresa

2014-10-01

To analyse the association between alcohol advertising restrictions and the prevalence of hazardous drinking among people aged 50-64 years in 16 European countries, taking into account both individual and contextual-level factors (alcohol taxation, availability, etc.). Cross-sectional study based on SHARE project surveys. A total of 27 773 subjects, aged 50-64 years, from 16 European countries who participated in wave 4 of the SHARE (Survey of Health, Ageing and Retirement in Europe) project. We estimated the prevalence of hazardous drinking (through adaptation of the SHARE questions to the scheme used by the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) for each country. To determine whether the degree of advertising restrictions was associated with prevalence of hazardous drinking, we fitted robust variance multi-level Poisson models, adjusting for various individual and contextual variables. Prevalence ratios (PR) and their 95% confidence intervals (95% CI) were obtained. The observed prevalence of hazardous drinking was 24.1%, varying by sex and country. Countries with greater advertising restrictions had lower prevalence of hazardous drinking: 30.6% (95% CI = 29.3-31.8) in countries with no restrictions, 20.3% (95% CI = 19.3-21.2) in countries with some restrictions and 14.4% (95% CI = 11.9-16.8) in those with greatest restrictions. The PR found (with respect to countries with greatest restrictions) were 1.36 (95% CI = 0.90-2.06) for countries with some restrictions and 1.95 (95% CI = 1.31-2.91) for those with no advertising restrictions. The extent of advertising restrictions in European countries is associated inversely with prevalence of hazardous drinking in people aged 50-64 years. © 2014 Society for the Study of Addiction.

The European Status Quo in legal recognition and patient-care services of occupational skin cancer.

PubMed

Ulrich, C; Salavastru, C; Agner, T; Bauer, A; Brans, R; Crepy, M N; Ettler, K; Gobba, F; Goncalo, M; Imko-Walczuk, B; Lear, J; Macan, J; Modenese, A; Paoli, J; Sartorelli, P; Stageland, K; Weinert, P; Wroblewski, N; Wulf, H C; John, S M

2016-04-01

Skin cancer is the most common malignancy in Caucasian populations worldwide and ultraviolet radiation (UVR) is known for being the number one carcinogen. As, especially in outdoor workers, UVR is an inevitable carcinogen, the prevention and management of UVR-related skin cancers in these at-risk populations represent a collective challenge for dermatologists and healthcare policymakers likewise. To provide an overview on the current regulations on the acknowledgement and management of work-related skin cancer in 11 European countries. Dermatologists from 11 countries networking within the EU Horizon 2020 COST Action TD1206 'StanDerm' contributed to a standardized survey regarding current national regulations, implemented for the recognition, prevention and management as well as possible compensation regulations in their individual country of residence. Ten of 11 participating countries in this survey reported the existence of an established programme available on certain occupational diseases; work-related skin diseases were only specifically recognized in eight countries. Seven of 11 countries recognize cutaneous squamous cell carcinoma in outdoor workers as 'occupational skin cancer'. Basal cell carcinoma (6 of 11), actinic keratosis (5 of 11), Bowen's disease (5 of 11) and malignant melanoma (5 of 11) are not as regularly approved as potentially 'work-induced'. Only a few of the countries included into this survey established a general documentation system (national registry) on occupational skin diseases. So far, representatives of only three countries of this survey referred to a specific established national programme for the prevention, management or compensation of occupational skin cancers acquired during work-related UVR exposure. This survey highlights the need for mandatory regulations on the prevention, management and potential compensation of work-related UV-induced skin cancer across Europe. Against the background of a joint European domestic market

How resilient are Europe's inshore fishing communities to change? Differences between the north and the south.

PubMed

Hadjimichael, Maria; Delaney, Alyne; Kaiser, Michel J; Edwards-Jones, Gareth

2013-12-01

One would hypothesize that the Common Fisheries Policy, as the umbrella framework for fisheries management in the EU would have the greatest impact on fishers' communities across Europe. There are, however, biological, economic, social, and political factors, which vary among fishing communities that can affect how these communities react to changes. This paper explores the links between institutional arrangements and ecological dynamics in two European inshore fisheries socio-ecological systems, using a resilience framework. The Mediterranean small-scale fishers do not seem to have been particularly affected by the Common Fisheries Policy regulations but appear affected by competition with the politically strong recreational fishers and the invasion of the rabbit fish population. The inshore fishers along the East coast of Scotland believe that their interests are not as sufficiently protected as the interests of their offshore counterpart. Decisions and initiatives at global, EU, and sometimes national level, tend to take into account those fisheries sectors which have a national economic importance. A socio-ecological analysis can shift the focus from biological and economic aspects to more sustainable long-term delivery of environmental benefits linked to human wellbeing.

A socio-cultural instrumental approach to emotion regulation: Culture and the regulation of positive emotions.

PubMed

Ma, Xiaoming; Tamir, Maya; Miyamoto, Yuri

2018-02-01

We propose a sociocultural instrumental approach to emotion regulation. According to this approach, cultural differences in the tendency to savor rather than dampen positive emotions should be more pronounced when people are actively pursuing goals (i.e., contexts requiring higher cognitive effort) than when they are not (i.e., contexts requiring lower cognitive efforts), because cultural beliefs about the utility of positive emotions should become most relevant when people are engaging in active goal pursuit. Four studies provided support for our theory. First, European Americans perceived more utility and less harm of positive emotions than Japanese did (Study 1). Second, European Americans reported a stronger relative preference for positive emotions than Asians, but this cultural difference was larger in high cognitive effort contexts than in moderate or low cognitive effort contexts (Study 2). Third, European Americans reported trying to savor rather than dampen positive emotions more than Asians did when preparing to take an exam, a typical high cognitive effort context (Studies 3-4), but these cultural differences were attenuated when an exam was not expected (Study 3) and disappeared when participants expected to interact with a stranger (Study 4). These findings suggest that cultural backgrounds and situational demands interact to shape how people regulate positive emotions. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Differential regulation of luteinizing hormone and follicle-stimulating hormone expression during ovarian development and under sexual steroid feedback in the European eel.

PubMed

Schmitz, Monika; Aroua, Salima; Vidal, Bernadette; Le Belle, Nadine; Elie, Pierre; Dufour, Sylvie

2005-01-01

Pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are, in teleosts as in mammals, under the control of hypothalamic factors and steroid feedbacks. In teleosts, feedback regulations largely vary depending on species and physiological stage. In the present study the regulation of FSH and LH expression was investigated in the European eel, a fish of biological and phylogenetical interest as a representative of an early group of teleosts. The eel FSHbeta subunit was cloned, sequenced and together with earlier isolated eel LHbeta and glycoprotein hormone alpha (GPalpha) subunits used to study the differential regulation of LH and FSH. In situ hybridization indicated that FSHbeta and LHbeta are expressed by separate cells of the proximal pars distalis of the adenohypophysis, differently from the situation in mammals. The profiles of LHbeta and FSHbeta subunit expression were compared during experimental ovarian maturation, using dot-blot assays. Expression levels for LHbeta and GPalpha increased throughout ovarian development with a positive correlation between these two subunits. Conversely, FSHbeta mRNA levels decreased. To understand the role of sex steroids in these opposite variations, immature eels were treated with estradiol (E2)and testosterone (T), both steroids being produced in eel ovaries during gonadal development. E2 treatment induced increases in both LHbeta and GPalpha mRNA levels, without any significant effect on FSHbeta. In contrast, T treatment induced a decrease in FSHbeta mRNA levels, without any significant effect on the other subunits. These data demonstrate that steroids exert a differential feedback on eel gonadotropin expression, with an E2-specific positive feedback on LH and a T-specific negative feedback on FSH, leading to an opposite regulation of LH and FSH during ovarian development. Copyright 2005 S. Karger AG, Basel

Perspectives for food research and European collaboration in the European Research Area and the new Framework Programme.

PubMed

Breslin, L

2001-08-01

Since 1987, successive framework programmes have contributed to strengthen European food research through the establishment of networks between research institutions, universities and companies from various European countries. In the FAIR programme (1994-1998), 118 research projects comprising nearly 1,000 participants from the European Union and Associated States have been supported in the food area with a European funding of about [symbol: see text] 108 million. Within the Quality of Life and Management of Living Resources programme (1998-2002), food research is mostly supported within the key action 'food, nutrition and health' with a budget of [symbol: see text] 290 million. After the first four deadlines, 735 eligible research proposals have already been received. Further to their evaluation by a panel of independent experts, 108 proposals have been funded or selected for funding representing a total contribution of about [symbol: see text] 168 million. Among those, several clusters of projects are now running on important topics such as probiotics, coeliac diseases, mycotoxins, GMO, safety and food for the elderly. In addition, technology stimulation measures are largely benefiting SMEs to foster their innovation potential. In January 2000, the European Commission adopted a Communication entitled "Towards the European Research Area (ERA)" with the objective to contribute to developing better framework conditions for research in Europe. On 21 February 2001, the Commission adopted proposals to be submitted to the European Parliament and Council for the next framework programme for research and innovation (2002-2006). The new framework programme that is becoming one of the financial instruments of the ERA aims at catalysing the integration of European research by: strengthening of links between the Community research effort and national and regional research policies; concentrating on a limited number of priority fields or research to which activities at the

Comparison of infectious waste management in European hospitals.

PubMed

Mühlich, M; Scherrer, M; Daschner, F D

2003-12-01

A research project sponsored by the EC-LIFE programme was conducted to compare waste management in five different European hospitals. A comparison of the regulations governing current waste management revealed different strategies for defining infectious hospital waste. The differences in the infrastructure were examined and the consequences for waste segregation and disposal were discussed under economic and ecological aspects. In this context the definition of infectious waste is very important.

75 FR 61035 - Community Reinvestment Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-04

... nonminority-owned and nonwomen-owned financial institutions in cooperation with minority- and women-owned... community, including low- and moderate- income neighborhoods, consistent with the safe and sound operation... Opportunity Act, Public Law 110-315, 122 Stat. 3078 (August 14, 2008) (the ``HEOA''), which amended the CRA...

Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union.

PubMed

Annys, Erwin; Billington, Richard; Clayton, Rick; Bremm, Klaus-Dieter; Graziano, Michael; McKelvie, Jo; Ragan, Ian; Schwarz, Michael; van der Laan, Jan Willem; Wood, Charles; Öberg, Mattias; Wester, Piet; Woodward, Kevin N

2014-07-01

Different government agencies operating in the European Union regulate different types of chemical products but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where representatives of the pharmaceutical, animal health, chemical and plant protection industries, together with representatives of regulatory agencies, universities and other stakeholders, met under the auspices of The European Partnership for Alternative Approaches to Animal Testing (EPAA) to discuss the varying requirements for carcinogenicity testing, and how these studies might be refined to improve hazard evaluation and risk assessment while implementing principles of the 3Rs (replacement, refinement and reduction in animal studies). While there are some similarities, the regulatory approaches in pharmaceutical, animal health, chemical and plant protection sectors have varying degrees of flexibility in requirements for carcinogenicity testing, to an extent reflecting concerns over the magnitude and duration of human exposure, either directly as in therapeutic exposure to pharmaceuticals, or indirectly through the ingestion of residues of veterinary drugs or plant protection chemicals. The article discusses these differences and other considerations for modified carcinogenicity testing paradigms on the basis of scientific and 3Rs approaches. Copyright © 2014 Elsevier Inc. All rights reserved.

Medicaid program; state plan home and community-based services, 5-year period for waivers, provider payment reassignment, and home and community-based setting requirements for Community First Choice and home and community-based services (HCBS) waivers. Final rule.

PubMed

2014-01-16

This final rule amends the Medicaid regulations to define and describe state plan section 1915(i) home and community-based services (HCBS) under the Social Security Act (the Act) amended by the Affordable Care Act. This rule offers states new flexibilities in providing necessary and appropriate services to elderly and disabled populations. This rule describes Medicaid coverage of the optional state plan benefit to furnish home and community based-services and draw federal matching funds. This rule also provides for a 5-year duration for certain demonstration projects or waivers at the discretion of the Secretary, when they provide medical assistance for individuals dually eligible for Medicaid and Medicare benefits, includes payment reassignment provisions because state Medicaid programs often operate as the primary or only payer for the class of practitioners that includes HCBS providers, and amends Medicaid regulations to provide home and community-based setting requirements related to the Affordable Care Act for Community First Choice State plan option. This final rule also makes several important changes to the regulations implementing Medicaid 1915(c) HCBS waivers.

The "Volcano Observations" Thematic Core Service of the European Plate Observing System (EPOS): status of the implementation.

NASA Astrophysics Data System (ADS)

Puglisi, Giuseppe

2017-04-01

The European volcanological community contributes to implementation of European Plate Observing System (EPOS) by making operational an integrated platform to guarantee a seamless access to the data provided by the European Solid Earth communities. To achieve this objective, the Volcano Observations Work Package (WP11) will implement a Thematic Core Services (TCS) which is planned to give access to the data and services provided by the European Volcano Observatories (VO) and some Volcanological Research Institutions (VRI; as university departments, laboratories, etc.); both types are considered as national research infrastructures (RI) over which to build the TCS. Currently, the networks on European volcanoes consist of thousands of stations or sites where volcanological parameters are continuously or periodically measured. These sites are equipped with instruments for geophysical (seismic, geodetic, gravimetric, electromagnetic), geochemical (volcanic plumes, fumaroles, groundwater, rivers, soils), environmental observations (e.g. meteorological and air quality parameters), as well as various prototypal monitoring systems (e.g. Doppler radars, ground based SAR). In Europe also operate laboratories for sample analysis (rocks, gases, isotopes, etc.), and almost continuous analysis of space-borne data (SAR, thermal imagery, SO2 and ash), as well as high-performance computing centres. All these RIs provide high-quality information (observations) on the current status of European volcanoes and the geodynamic background of the surrounding areas. The implementation of the Volcano Observations TCS is addressing technical and management issues, both considering the current heterogeneous state of the art of the volcanological research infrastructures in Europe. Indeed, the frame of the VO and VRI is now too fragmented to be considered as a unique distributed infrastructure, thus the main effort planned in the frame of the EPOS-IP is focused to create services aimed at

Can harmonized regulation overcome intra-European differences? Insights from a European Phase III stem cell trial.

PubMed

Hauskeller, Christine

2017-09-01

Harmonized regulation of research with human stem cells in Europe has shaped innovation in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous cell procedure illustrate the obstacles that a multinational trial faces. A typology of the obstacles encountered, may help other teams embarking upon trials. The findings throw light on the situation of clinician-scientists in clinical innovation, as the expertise to run scientific trials is very complex. The innovation route of clinical translation takes insufficient account of the interdependencies between multiple social and cultural factors from outside the laboratory and the clinic. For ethical reasons, however, academic and business routes to stem cell treatments ought to be enabled by the regulators. Suggestions arise, how academics can prepare for trials, that academic research needs better institutional support and that new models of medical innovation may need to be developed for regenerative medicine.

Discovering History at the Community College

ERIC Educational Resources Information Center

Tai, Emily Sohmer

2013-01-01

Many of the history courses community college students take are fairly broad and ostensibly generic surveys of world, Western European, or American history. This chapter discusses an array of innovative practices that enable students to better appreciate how studying history can help them master the challenges--and reap the benefits--of a liberal…

Seaweeds: an opportunity for wealth and sustainable livelihood for coastal communities.

PubMed

Rebours, Céline; Marinho-Soriano, Eliane; Zertuche-González, José A; Hayashi, Leila; Vásquez, Julio A; Kradolfer, Paul; Soriano, Gonzalo; Ugarte, Raul; Abreu, Maria Helena; Bay-Larsen, Ingrid; Hovelsrud, Grete; Rødven, Rolf; Robledo, Daniel

2014-01-01

The European, Canadian, and Latin American seaweed industries rely on the sustainable harvesting of natural resources. As several countries wish to increase their activity, the harvest should be managed according to integrated and participatory governance regimes to ensure production within a long-term perspective. Development of regulations and directives enabling the sustainable exploitation of natural resources must therefore be brought to the national and international political agenda in order to ensure environmental, social, and economic values in the coastal areas around the world. In Europe, Portugal requires an appraisal of seaweed management plans while Norway and Canada have developed and implemented coastal management plans including well-established and sustainable exploitation of their natural seaweed resources. Whereas, in Latin America, different scenarios of seaweed exploitation can be observed; each country is however in need of long-term and ecosystem-based management plans to ensure that exploitation is sustainable. These plans are required particularly in Peru and Brazil, while Chile has succeeded in establishing a sustainable seaweed-harvesting plan for most of the economically important seaweeds. Furthermore, in both Europe and Latin America, seaweed aquaculture is at its infancy and development will have to overcome numerous challenges at different levels (i.e., technology, biology, policy). Thus, there is a need for regulations and establishment of "best practices" for seaweed harvesting, management, and cultivation. Trained human resources will also be required to provide information and education to the communities involved, to enable seaweed utilization to become a profitable business and provide better income opportunities to coastal communities.

The "visibility" of West European astronomical research.

NASA Astrophysics Data System (ADS)

Jaschek, C.

Publications and citations of five West European astronomical communities (Switzerland, Sweden, GFR, France and Spain) are compared. A large proportion of astronomers are sparsely cited or not cited at all, a fact which shows that estimations of the number of scientists based upon citation statistics are underestimates. It is found that publication rates are similar but citation rates very dissimilar in the five countries. No clear explanation of these differences is found, except for Spain. A plea is made to use citation statistics rather than publication statistics for evaluation.

Spatial and seasonal variation in diversity and structure of microbial biofilms on marine plastics in Northern European waters.

PubMed

Oberbeckmann, Sonja; Loeder, Martin G J; Gerdts, Gunnar; Osborn, A Mark

2014-11-01

Plastic pollution is now recognised as a major threat to marine environments and marine biota. Recent research highlights that diverse microbial species are found to colonise plastic surfaces (the plastisphere) within marine waters. Here, we investigate how the structure and diversity of marine plastisphere microbial community vary with respect to season, location and plastic substrate type. We performed a 6-week exposure experiment with polyethylene terephthalate (PET) bottles in the North Sea (UK) as well as sea surface sampling of plastic polymers in Northern European waters. Scanning electron microscopy revealed diverse plastisphere communities comprising prokaryotic and eukaryotic microorganisms. Denaturing gradient gel electrophoresis (DGGE) and sequencing analysis revealed that plastisphere microbial communities on PET fragments varied both with season and location and comprised of bacteria belonging to Bacteroidetes, Proteobacteria, Cyanobacteria and members of the eukaryotes Bacillariophyceae and Phaeophyceae. Polymers sampled from the sea surface mainly comprised polyethylene, polystyrene and polypropylene particles. Variation within plastisphere communities on different polymer types was observed, but communities were primarily dominated by Cyanobacteria. This research reveals that the composition of plastisphere microbial communities in marine waters varies with season, geographical location and plastic substrate type. © 2014 Federation of European Microbiological Societies. Published by John Wiley & Sons Ltd. All rights reserved.

Soil moisture--a regulator of arbuscular mycorrhizal fungal community assembly and symbiotic phosphorus uptake.

PubMed

Deepika, Sharma; Kothamasi, David

2015-01-01

Multiple species of arbuscular mycorrhizal fungi (AMF) can colonize roots of an individual plant species but factors which determine the selection of a particular AMF species in a plant root are largely unknown. The present work analysed the effects of drought, flooding and optimal soil moisture (15-20 %) on AMF community composition and structure in Sorghum vulgare roots, using PCR-RFLP. Rhizophagus irregularis (isolate BEG 21), and rhizosphere soil (mixed inoculum) of Heteropogon contortus, a perennial C4 grass, collected from the semi-arid Delhi ridge, were used as AMF inocula. Soil moisture functioned as an abiotic filter and affected AMF community assembly inside plant roots by regulating AMF colonization and phylotype diversity. Roots of plants in flooded soils had lowest AMF diversity whilst root AMF diversity was highest under the soil moisture regime of 15-20 %. Although plant biomass was not affected, root P uptake was significantly influenced by soil moisture. Plants colonized with R. irregularis or mixed AMF inoculum showed higher root P uptake than non-mycorrhizal plants in drought and control treatments. No differences in root P levels were found in the flooded treatment between plants colonized with R. irregularis and non-mycorrhizal plants, whilst under the same treatment, root P uptake was lower in plants colonized with mixed AMF inoculum than in non-mycorrhizal plants.

Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries.

PubMed

Santos-Eggimann, Brigitte; Cuénoud, Patrick; Spagnoli, Jacques; Junod, Julien

2009-06-01

Frailty is an indicator of health status in old age. Its frequency has been described mainly for North America; comparable data from other countries are lacking. Here we report on the prevalence of frailty in 10 European countries included in a population-based survey. Cross-sectional analysis of 18,227 randomly selected community-dwelling individuals 50 years of age and older, enrolled in the Survey of Health, Aging and Retirement in Europe (SHARE) in 2004. Complete data for assessing a frailty phenotype (exhaustion, shrinking, weakness, slowness, and low physical activity) were available for 16,584 participants. Prevalences of frailty and prefrailty were estimated for individuals 50-64 years and 65 years of age and older from each country. The latter group was analyzed further after excluding disabled individuals. We estimated country effects in this subset using multivariate logistic regression models, controlling first for age, gender, and then demographics and education. The proportion of frailty (three to five criteria) or prefrailty (one to two criteria) was higher in southern than in northern Europe. International differences in the prevalences of frailty and prefrailty for 65 years and older group persisted after excluding the disabled. Demographic characteristics did not account for international differences; however, education was associated with frailty. Controlling for education, age and gender diminished the effects of residing in Italy and Spain. A higher prevalence of frailty in southern countries is consistent with previous findings of a north-south gradient for other health indicators in SHARE. Our data suggest that socioeconomic factors like education contribute to these differences in frailty and prefrailty.

Biopesticides--towards increased consumer safety in the European Union.

PubMed

Czaja, Katarzyna; Góralczyk, Katarzyna; Struciński, Paweł; Hernik, Agnieszka; Korcz, Wojciech; Minorczyk, Maria; Łyczewska, Monika; Ludwicki, Jan K

2015-01-01

The introduction of new food safety regulations in the European Union has resulted in the withdrawal of many synthetic active substances used in plant protection products, in light of their potential or actual harmful effect on human and animal health, as well as on the environment. Alternatives to these compounds are being developed - naturally occurring pesticides, also referred to as biopesticides. The use of biopesticides in crop protection leads to decreased levels of pesticide residues in foods, and as a result to lower risk levels for the consumer. Biologically active agents defined as biopesticides are varied, and therefore application of the same environmental and consumer safety criteria to all of them is impossible. This presents serious complications in the approval of these pesticides as active plant protection products and in their registration. It needs to be stressed that, in the registration procedure of the European Union, biopesticides are subject to the same regulations as synthetic active substances. This situation has resulted in the need to introduce numerous new provisions in the legislation, as well as the preparation of new guidelines facilitating the registration of biopesticides. These activities aim to promote naturally originating pesticides. © 2014 Society of Chemical Industry.

Incineration of European non-nuclear radioactive waste in the USA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moloney, B. P.; Ferguson, D.; Stephenson, B.

2013-07-01

Incineration of dry low level radioactive waste from nuclear stations is a well established process achieving high volume reduction factors to minimise disposal costs and to stabilise residues for disposal. Incineration has also been applied successfully in many European Union member countries to wastes arising from use of radionuclides in medicine, nonnuclear research and industry. However, some nations have preferred to accumulate wastes over many years in decay stores to reduce the radioactive burden at point of processing. After decay and sorting the waste, they then require a safe, industrial scale and affordable processing solution for the large volumes accumulated.more » This paper reports the regulatory, logistical and technical issues encountered in a programme delivered for Eckert and Ziegler Nuclitec to incinerate safely 100 te of waste collected originally from German research, hospital and industrial centres, applying for the first time a 'burn and return' process model for European waste in the US. The EnergySolutions incinerators at Bear Creek, Oak Ridge, Tennessee, USA routinely incinerate waste arising from the non-nuclear user community. To address the requirement from Germany, EnergySolutions had to run a dedicated campaign to reduce cross-contamination with non-German radionuclides to the practical minimum. The waste itself had to be sampled in a carefully controlled programme to ensure the exacting standards of Bear Creek's license and US emissions laws were maintained. Innovation was required in packaging of the waste to minimise transportation costs, including sea freight. The incineration was inspected on behalf of the German regulator (the BfS) to ensure suitability for return to Germany and disposal. This first 'burn and return' programme has safely completed the incineration phase in February and the arising ash will be returned to Germany presently. The paper reports the main findings and lessons learned on this first of its kind

Do no harm: the role of community pharmacists in regulating public access to prescription drugs in Saudi Arabia.

PubMed

Bahnassi, Anas

2016-04-01

Pharmacists have a crucial role to ensure regulated public access to prescription drugs. The study aimed to investigate the views of community pharmacists practising in Saudi Arabia on their role in the unauthorised supply of prescription drugs, consider the possible contributory factors and report pharmacists' suggested strategies to regulate supply. One hundred community pharmacists were invited to participate in an interview-based survey, including questions on demographic characteristics, and the unauthorised supply of prescription drugs. Descriptive statistics were conducted, and associations between categorical responses tested; a P value of ≤0.05 was considered significant. Responses to open questions were analysed thematically. In Saudi Arabia, there is widespread unregulated supply of prescription drugs; pharmacists are under pressure from patients to provide prescription drugs for a wide range of clinical conditions. There are safety and appropriateness concerns when drugs are provided based on patient demand rather than clinical need. Pharmacists do not maintain patient records with information on drugs supplied and associated actions. While most pharmacists supply prescription drugs without the necessary prescriber authorisation, they also this may jeopardise patients safety. While we have many concerns about this practice its present form, we believe pharmacists should have certain prescribing privileges within their areas of competence. A legal framework is needed to guarantee proper pharmacists' training, support, mentorship and access to the tools required to provide safe pharmacy practice. © 2015 Royal Pharmaceutical Society.

Psychosocial working conditions and psychological well-being among employees in 34 European countries.

PubMed

Schütte, Stefanie; Chastang, Jean-François; Malard, Lucile; Parent-Thirion, Agnès; Vermeylen, Greet; Niedhammer, Isabelle

2014-11-01

The aim of this study was to explore the associations between psychosocial working conditions and psychological well-being among employees in 34 European countries. Another objective was to examine whether these associations varied according to occupation and country. The study was based on data from the European Working Conditions Survey 2010 including 33,443 employees, 16,512 men and 16,931 women, from 34 European countries. Well-being was measured by the WHO-5 well-being index. Twenty-five psychosocial work factors were constructed including job demands, role stressors, work hours, job influence and freedom, job promotion, job insecurity, social support, quality of leadership, discrimination and violence at work, and work-life imbalance. The associations between these factors and well-being were examined using multilevel logistic regression analyses. Different models were performed including interaction tests. When all 25 psychosocial work factors were studied simultaneously in the same model with adjustment variables, 13 showed a significant association with poor well-being among both genders: quantitative demands, demands for hiding emotions, low possibilities for development, low meaning of work, low role conflict, low quality of leadership, low social support, low sense of community, job insecurity, low job promotion, work-life imbalance, discrimination, and bullying. The association with low sense of community on poor well-being was particularly strong. A large number of psychosocial work factors were associated with poor well-being. Almost no country and occupational differences were found in these associations. This study gave a first European overview and could be useful to inform cross-national policy debate.

What can we learn from the first community-based epidemiological study on stalking in Germany?

PubMed

Dressing, Harald; Gass, Peter; Kuehner, Christine

2007-01-01

There is a lack of community-based studies on prevalence rates of stalking and the impact of stalking on victims in continental European countries. The authors published the first community-based epidemiological study on stalking in Germany. The purpose of this paper is to discuss possible implications of these epidemiological data for the mental health system, forensic psychiatry and legal regulations in Germany. For these reasons some data of our epidemiological study are outlined and reanalyzed. To examine lifetime and point prevalence rates of stalking, behavioural and psychological consequences for victims and the impact of stalking on current psychological well-being in a German community sample, a postal survey was conducted with 2000 inhabitants randomly selected from Mannheim (response rate 34.2%, n=679). The survey included a stalking questionnaire and the WHO-5 well-being scale. Almost 12% of the respondents reported having been stalked. This study identified a high lifetime prevalence of stalking in the community. Effects on victims' psychological health were significant and there was a high rate of physical (31%) and sexual (19%) violence in the context of stalking. Our data suggest that the phenomenon deserves more attention in future forensic psychiatric research and practice. Implications for forensic psychiatric assessment and treatment of stalkers as well as for management of stalking victims are discussed.

Behavioural effects of a community-oriented setting-based intervention for prevention of childhood obesity in eight European countries. Main results from the IDEFICS study.

PubMed

De Bourdeaudhuij, I; Verbestel, V; De Henauw, S; Maes, L; Huybrechts, I; Mårild, S; Eiben, G; Moreno, L A; Barba, G; Kovács, É; Konstabel, K; Tornaritis, M; Gallois, K; Hebestreit, A; Pigeot, I

2015-12-01

The objective of this paper is to evaluate the behavioural effects, as reported by the parents of the participating boys and girls, of the IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS) intervention. The effectiveness of the IDEFICS intervention was evaluated through a cluster-controlled trial in eight European countries (control and intervention communities in each country) including more than 16,000 children. The 2- to 9.9-year-old children in the intervention group were exposed to a culturally adapted intervention that aimed to prevent childhood obesity through the community, schools/kindergartens and family. Parents completed questionnaires to measure water, soft drink and fruit juice intake; fruit and vegetable intake; daily TV viewing and other sedentary behaviours; daily physical activity levels and strengthening of the parent-child relationships at baseline and follow-up (2 years later). Mixed models with an additional random effect for country were used to account for the clustered study design, and results were stratified by sex. The pan-European analysis revealed no significant time by condition interaction effects, neither for boys nor girls, i.e. the analysis revealed no intervention effects on the behaviours of the IDEFICS children as reported by their parents (F = 0.0 to 3.3, all p > 0.05). Also very few significances were found in the country-specific analyses. Positive intervention effects were only found for sport club participation in Swedish boys, for screen time in weekends for Spanish boys and for TV viewing in Belgian girls. Although no expected intervention effects as reported by the parents on diet, physical activity and sedentary behaviours could be shown for the overall IDEFICS cohort, a few favourable intervention effects were found on specific behaviours in some individual countries. More in-depth analyses of the process evaluation data are needed to obtain more

75 FR 36016 - Community Reinvestment Act Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

... tracts affected by high levels of loan delinquencies and foreclosures. Among the many consequences of... homes in default or delinquency in each State or unit of general local government. Under NSP1, each of... Congressional intent that the funds have maximum impact and be targeted to States and local communities with the...

Building the European Seismological Research Infrastructure: results from 4 years NERIES EC project

NASA Astrophysics Data System (ADS)

van Eck, T.; Giardini, D.

2010-12-01

The EC Research Infrastructure (RI) project, Network of Research Infrastructures for European Seismology (NERIES), implemented a comprehensive European integrated RI for earthquake seismological data that is scalable and sustainable. NERIES opened a significant amount of additional seismological data, integrated different distributed data archives, implemented and produced advanced analysis tools and advanced software packages and tools. A single seismic data portal provides a single access point and overview for European seismological data available for the earth science research community. Additional data access tools and sites have been implemented to meet user and robustness requirements, notably those at the EMSC and ORFEUS. The datasets compiled in NERIES and available through the portal include among others: - The expanded Virtual European Broadband Seismic Network (VEBSN) with real-time access to more then 500 stations from > 53 observatories. This data is continuously monitored, quality controlled and archived in the European Integrated Distributed waveform Archive (EIDA). - A unique integration of acceleration datasets from seven networks in seven European or associated countries centrally accessible in a homogeneous format, thus forming the core comprehensive European acceleration database. Standardized parameter analysis and actual software are included in the database. - A Distributed Archive of Historical Earthquake Data (AHEAD) for research purposes, containing among others a comprehensive European Macroseismic Database and Earthquake Catalogue (1000 - 1963, M ≥5.8), including analysis tools. - Data from 3 one year OBS deployments at three sites, Atlantic, Ionian and Ligurian Sea within the general SEED format, thus creating the core integrated data base for ocean, sea and land based seismological observatories. Tools to facilitate analysis and data mining of the RI datasets are: - A comprehensive set of European seismological velocity reference

76 FR 56262 - Community Advantage Pilot Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... SMALL BUSINESS ADMINISTRATION [Docket No. SBA 2011-0003] Community Advantage Pilot Program AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of change to Community Advantage Pilot... Community Advantage Pilot Program. In that notice, SBA modified or waived as appropriate certain regulations...

The methodology for defining the European Standards for the certification of Haemophilia Centres in Europe

PubMed Central

Candura, Fabio; Menichini, Ivana; Calizzani, Gabriele; Giangrande, Paul; Mannucci, Pier Mannuccio; Makris, Michael

2014-01-01

Introduction Work Package 4 Development of the standardisation criteria of the European Haemophilia Network project has the main objective of implementing a common and shared European strategy for a certification system for two levels of Haemophilia Centres: European Haemophilia Treatment Centres and European Haemophilia Comprehensive Care Centres in the Member States of the European Union. Materials and methods An inclusive and participatory process for developing shared standards and criteria for the management of patients with inherited bleeding disorders has been carried out. The process has been implemented through four different consultation events involving the entire European community of stakeholders that significantly contributed in the drafting of the European Guidelines for the certification of Haemophilia Centres. Results The Guidelines set the standards for the designation of centres that provide specialised and multidisciplinary care (Haemophilia Comprehensive Care Centres) as well as local routine care (Haemophilia Treatment Centres). Standards cover several issues such as: general requirements; patient care; advisory services; laboratory; networking of clinical and specialised services. Conclusions The drafting of the European Guidelines for the certification of Haemophilia Centres was performed adopting a rigorous methodological approach. In order to build the widest possible consensus to the quality standards, the main institutional and scientific stakeholders have been involved. The resulting document will significantly contribute in promoting standardisation in the quality of diagnosis and treatment in European Haemophilia Centres. PMID:24922292

European Union health policy and its implications for national convergence.

PubMed

Cucic, S

2000-06-01

This paper explores the relevance for health care of European Union (EU) legislation, regulation and policies. Reports, communications and other materials of the European Commission and other relevant European bodies are screened for their implications for health care, primarily on the national health system level. The paper provides a brief overview of EU history and its main institutions, followed by an analysis of health (care)-related provisions in the EU's main legal documents--its treaties. The impact of the EU actions on health protection is considered with regard to both actions in the field of public health and health protection requirements in its policies. In the public health area, information systems that are now being developed are discussed, followed by an outline of health protection requirements in EU policies that can have an impact on health systems. These policies are then analysed using the political factions model. Finally an attempt is made to predict future developments, stressing the need for a far-reaching synchronization of national systems.

Regulatory structures for gene therapy medicinal products in the European Union.

PubMed

Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

2012-01-01

Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the framework of protection against oxidative damage and cardiovascular health.

PubMed

Martini, D; Rossi, S; Biasini, B; Zavaroni, I; Bedogni, G; Musci, M; Pruneti, C; Passeri, G; Ventura, M; Di Nuzzo, S; Galli, D; Mirandola, P; Vitale, M; Dei Cas, A; Bonadonna, R C; Del Rio, D

2017-06-01

The high number of negative opinions from the European Food Safety Authority (EFSA) to the requests for authorization of health claims is largely due to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed to collect, collate and critically analyse the information in relation to claimed effects, OVs and MMs, in the context of protection against oxidative damage and cardiovascular health compliant with Regulation 1924/2006. Claimed effects, OVs and the related MMs were collected from EFSA Guidance documents and applications for authorization of health claims under Articles 13.5 and 14. The OVs and their MMs were evaluated only if the claimed effect was sufficiently defined and was considered beneficial by EFSA. The collection, collation and critical analysis of the relevant scientific literature consisted in the definition of the keywords, the PubMed search strategies and the creation of databases of references. The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context of the specific claimed effects. The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims, as well as to the stakeholders for the proper design of human intervention studies aimed to substantiate such health claims. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

International laser-safety regulations: a status update

NASA Astrophysics Data System (ADS)

Weiner, Robert M.

1990-07-01

There is an increase in international laser safety requirements as part of the emphasis on world-wide standardization of products and regulations. In particular the documents which will evolve from the 1992 consolidation efforts of the European Community (EC) will impact both laser manufacturers and users. This paper provides a discussion of the current status of the various laser radiation standards. NORTH AMERICAN REQUIREMENTS United States Requirements on manufacturers from the Food and Drug Administration (FDA) have been in effect since 1975. The Center for Devices and Radiological Health (CDRH) within that agency ensures that these mandatory requirements [1] are satisfied. The CDRH regulations include the division of products into classes depending on their potential for hazard criteria for power measurement and requirements for product features labels and manuals and records and reports. Manufacturers must test products and certify that they comply with the CDRH requirements. User requirements are found in a standard published by the American National Standards Institute (ANSI) and in requirements from several individual states. Specific ANSI standards have also been published for fiber communications systems [34] and for lasers in medical applications [35]. Please note that the Appendix includes additional information on the standards discussed in this paper including sources for obtaining the documents. Canada In the past Canada has had requirements for two specified product categories (bar code scanners and educational lasers) [26 These will be replaced

Spain at Europe’s Crossroads: Prospects for Spanish Integration to the North Atlantic Treaty Organization and the European Economic Community.

DTIC Science & Technology

1982-03-01

embryo European government is not taken seriously. Direct election of the European Parliament in 1979 was a gesture toward stronger institutional...Spanish past, Spaniards want to join in a common European destiny . They also want to consolidate the democratization that has been achieved by joining

Drivers of decomposition in forest soils: Insights from a trans-European experiment.

NASA Astrophysics Data System (ADS)

Hood-Nowotny, Rebecca

2017-04-01

Meta-data analyses and the model based hypotheses state that global soil C storage is controlled by microbial scale processes of fungal competition for available nitrogen (N). The details of these microbe-dependent feedback mechanisms on N and C dynamics in European soils are largely unknown and contentious. Global trends of increasing atmospheric N deposition and the continuing use of inorganic N fertilizer in both agriculture and forestry mean that the soils vital function as a carbon sink is potentially under threat. We set out to experimentally investigate these hypotheses across a Trans-European gradient of forest soils and provide reliable information on soil microbial responses to nitrogen inputs for predictive climate change models. Changes in nutrient status could result in a chain reaction of interacting microbial mechanisms which in turn could lead to the shifts in underlying ecosystem biogeochemical process rates. Recent meta-analysis has shown that plant fungal symbiont community structure, exerts a greater fundamental control over soil C storage than temperature, precipitation or net primary production. Based on the hypothesis that plant associated fungi effectively scavenge all available organic and inorganic N leaving little N for the growth of the free-living decomposer microbial community and preventing further breakdown of SOM. To investigate these possible effects we have sampled forest soils across a trans European gradient (ALTER-net-MSII network) which have received additional inputs of inorganic nitrogen fertilizer or carbon in the form of sugar, over a three year period. We have studied both nitrogen and carbon dynamics in these systems using a tool box of stable isotopes, high through-put sequencing for microbial community analysis and be-spoke litter bags to tease out the dominant drivers of decomposition. The results and conclusions from these analyses will be presented.

The European Marine Observing Network and the development of an Integrated European Ocean Observing System. An EuroGOOS perspective

NASA Astrophysics Data System (ADS)

Fernandez, Vicente; Gorringe, Patrick; Nolan, Glenn

2016-04-01

The ocean benefits many sectors of society, being the biggest reservoir of heat, water, carbon and oxygen and playing a fundamental role regulating the earth's climate. We rely on the oceans for food, transport, energy and recreation. Therefore, a sustained marine observation network is crucial to further our understanding of the oceanic environment and to supply scientific data to meet society's need. Marine data and observations in Europe, collected primarily by state governmental agencies, is offered via five Regional Operational Oceanographic Systems (ROOS) within the context of EuroGOOS (http://www.eurogos.eu), an International Non-Profit Association of national governmental agencies and research organizations (40 members from 19 member states) committed to European-scale operational oceanography within the context of the Intergovernmental Global Ocean Observing System (GOOS). Strong cooperation within these regions, enabling the involvement of additional partners and countries, forms the basis of EuroGOOS work. Ocean data collected from different type of sensors (e.g. moored buoys, tide gauges, Ferrybox systems, High Frequency radars, gliders and profiling floats) is accessible to scientist and other end users through data portals and initiatives such as the European Marine Observations and Data Network (EMODnet) (www.emodnet.eu) and the Copernicus Marine Service Copernicus (www.copernicus.eu). Although a relatively mature European ocean observing capability already exists and its well-coordinated at European level, some gaps have been identified, for example the demand for ecosystem products and services, or the case that biogeochemical observations are still relatively sparse particularly in coastal and shelf seas. Assessing gaps based on the capacity of the observing system to answer key societal challenges e.g. site suitability for aquaculture and ocean energy, oil spill response and contextual oceanographic products for fisheries and ecosystems is still

Macroinvertebrate community responses to gravel augmentation in a high-gradient, Southeastern regulated river

DOE Office of Scientific and Technical Information (OSTI.GOV)

McManamay, Ryan A; Orth, Dr. Donald J; Dolloff, Dr. Charles A

2013-01-01

Sediment transport, one of the key processes of river systems, is altered or stopped by dams, leaving lower river reaches barren of sand and gravel, both of which are essential habitat for fish and macroinvertebrates. One way to compensate for losses in sediment is to supplement gravel to river reaches below impoundments. Because gravel addition has become a widespread practice, it is essential to evaluate the biotic response to restoration projects in order to improve the efficacy of future applications. The purpose of our study was to evaluate the response of the macroinvertebrate community to gravel addition in a high-gradient,more » regulated river in western North Carolina. We collected benthic macroinvertebrate samples from gravel-enhanced areas and unenhanced areas for 1 season before gravel addition, and for 4 seasons afterwards. Repeated measures multivariate analysis of variance indicated that the responses of macroinvertebrates to gravel addition were generally specific to individual taxa or particular functional feeding groups and did not lead to consistent patterns in overall family richness, diversity, density, or evenness. Non-metric multi-dimensional scaling showed that shifts in macroinvertebrate community composition were temporary and dependent upon site conditions and season. Correlations between macroinvertebrate response variables and substrate microhabitat variables existed with or without the inclusion of data from enhanced areas, which suggests that substrate-biotic relationships were present before gravel addition. A review of the current literature suggests that the responses of benthic macroinvertebrates to substrate restoration are inconsistent and dependent upon site conditions and the degree habitat improvement of pre-restoration site conditions.« less

European Scale Earthquake Data Exchange: ORFEUS-EMSC Joint Initiatives

NASA Astrophysics Data System (ADS)

Bossu, R.; van Eck, T.

2003-04-01

The European-Mediterranean Seismological Centre (EMSC) and the Observatories and Research Facilities for European Seismology (ORFEUS) are both active international organisations with different co-ordinating roles within European seismology. Both are non-governmental non-profit organisations, which have members/participants in more than 30 countries in Europe and its surroundings. Although different, their activities are complementary with ORFEUS focusing on broadband waveform data archiving and dissemination and EMSC focusing on seismological parameter data. The main EMSC activities are the alert system for potentially damaging earthquakes, a real time seismicity web page, the production of the Euro-Med. seismological bulletin, and the creation and maintenance of databases related to seismic hazard. All these activities are based on data contributions from seismological Institutes. The EMSC is also involved in a UNESCO programme to promote seismology and data exchange in the Middle-East and Northern Africa. ORFEUS aims at co-ordinating and promoting digital broadband seismology in Europe. To accomplish this, it operates a Data Centre to archive and distribute high quality digital data for research, co-ordinates four working groups and provides services through the Internet. More recently through an EC-infrastructure project MEREDIAN it has accomplished added co-ordination of data exchange and archiving between large European national data centres and realised the Virtual European Broadband Seismograph Network (VEBSN). To accomplish higher efficiency and better services to the seismological community, ORFEUS and EMSC have been working towards a closer collaboration. Fruits of this collaboration are the joint EC project EMICES, a common Expression of Interest 'NERIES' submitted June 2002 to the EC , integration of the automatic picks from the VEBSN into the EMSC rapid alert system and collaboration on common web page developments. Presently, we collaborate in a

[European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation].

PubMed

Buljovčić, Z

2011-07-01

On 30 December 2008, the Regulation (EC) 1394/2007 on advanced therapy medicinal products (ATMPs) entered into force. Herewith the first EU-wide regulatory framework for ATMPs was established. It requires a central marketing authorisation application to the EMA (European Medicinal Agency). This new framework especially changes the code of regulatory practice for tissue engineered products (TEPs), as no registration procedure had been previously required for autologous TEPs. This also meant that no clinical proof of efficacy achieved by a pivotal clinical trial was necessary. Difficulties and their background as well as the vast requirements for product development that have to be addressed by small companies within a very short time frame are presented. Hereby, it is obvious that regulatory experience which is required to identify and implement the resulting implications was not in place yet and still had to be established. The lack of regulatory experience also resulted in difficulties with scientific advice preparation, expectations toward regulatory agencies, consultants, and transformation of regulatory requirements. Addressing the regulatory requirements within the transition period is even more difficult for entrepreneurs with products which are assigned for indications resulting in complex challenges to the trial design. Due to the enormous time pressure to generate data and due to the implied financial pressure, different adaptation strategies are evolving. In Germany the "hospital exemption" according to §4b AMG (German Medicinal Products Law) is of major importance. A reorientation toward acellular products and a slow down in development of new ATMP products is expected.

A Space for the European Higher Education Area: The Guidance from the EU Court of Justice to Member States