994 resultados para European Medicines Agency
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Sufficient cross‐border electricity transmission infrastructure is a pre‐requisite for a functioning European internal market for electricity. Also, the achievement of the EU’s energy policy objectives – sustainability, competitiveness and security of supply – critically depends on adequate investment in physical interconnections between the member states. Mainly focusing on the “regulatory path”, this paper assesses different ways to achieve a sufficient level of interconnector investment. In a first step, economic analysis identifies numerous impediments to interconnector investment adding up to an “interconnector investment failure”. Reflecting on the proper regulatory design of an EU framework able to overcome the interconnector investment failure, a number of recommendations are put forward: All congestion rents should be channeled into interconnector building. Unused rents should be transferred to a European interconnector fund supervised by an EU agency. Even though inherently sub‐optimal, merchant transmission investment can be used as a means to put pressure on regulated transmission system operators (TSO) that do not deliver. An EU agency should have exclusive competence on merchant interconnector exemptions. A European TSO organization should be entrusted with supra‐national network planning, supervised by an EU agency. The agency should decide on investment cost reallocation for interconnector projects that yield strong externalities. Payments could be settled via a European interconnector fund. In case of non‐compliance with the supra‐national network plan, the EU agency should have the right to organize a tender – financed by the European interconnector fund – in order to get the “missing link” built. Assessing the existing EU regulatory framework, the efforts of the 2009 “third energy package” to fill the “regulatory gap” with new EU bodies – ACER and ENTSO‐E – are acknowledged. However, striking holes in regulatory framework are spotted, notably with regard to the use of congestion rents, interconnector cost allocation, and the distribution of decision making powers on new infrastructure exemptions A discussion of the TEN‐E interconnector funding scheme shows that massive funding can be an interim solution to the problem of insufficient interconnection capacities while overcoming the political deadlock on sensible regulatory topics such as interconnector cost allocation. The paper ends with policy recommendations.
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Starting from the concept of delegation of power in external trade policy, this paper aims to investigate the dynamics surrounding the European Union’s position in international trade negotiations. The analysis centres on the role of the European Commission (the agent), which by means of Treaty-based delegation and as mandated by the Council (the principal) acts as the sole trade negotiator in the international sphere on behalf of the European Union (EU). The broader negotiating process is thus conceptualised as a threelevel game, where the Commission holds an intermediary position between the European and international levels and also interacts with the Member States in the Council. After an insight into the European decision-making process for external trade, the paper further analyses the Commission’s role during the multilateral trade negotiations of the Doha Development Round. By applying the principal-agent theory to international trade negotiations in general, and subsequently to the controversial agricultural negotiations, this paper seeks to investigate some of the potential sources of autonomy that the Commission can draw upon while upholding an EU position at the international level, in addition to the “hardball” job of balancing the interests of the Member States with those of World Trade Organisation (WTO) partners. Along these lines, the paper finally aims to contribute to the literature concerning agency autonomy in EU external trade relations but also to provide a better understanding of inter-institutional relations within the EU as they may unfold in practice.
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• The European quantitative easing programme, the Public Sector Purchase Programme (PSPP), started on 9 March 2015 and will last at least until September 2016. Purchases will be composed of sovereign bonds and securities from European institutions and national agencies. • The European Central Bank Governing Council imposed limits to ensure that the Eurosystem will not breach the prohibition on monetary financing. However, these limits will constrain the size and duration of the programme, especially if it is sustained after September 2016. The possibility for national central banks to also buy national agency securities could alleviate this, but the small number of eligible agencies could limit their role as a back-up purchase. • The Eurosystem should find other eligible agencies, especially in countries in which public debt is small, or waive the limits for countries respecting the investment grade eligibility criteria. The same issue arises with European institutions: their number and outstanding debt securities are limited. The waiver of the limits proposed for sovereigns should be applied to institutions with high ratings. • The PSPP profits that will ultimately be repatriated to national treasuries will be small. This was to be expected, given current very low yields. Profits will also come from the major increase in reserves resulting from the implementation of QE, combined with the negative deposit rates on excess reserves at the ECB.
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Summary. On 11 March 2011, a devastating earthquake struck Japan and caused a major nuclear accident at the Fukushima Daiichi nuclear plant. The disaster confirmed that nuclear reactors must be protected even against accidents that have been assessed as highly unlikely. It also revealed a well-known catalogue of problems: faulty design, insufficient back-up systems, human error, inadequate contingency plans, and poor communications. The catastrophe triggered the rapid launch of a major re-examination of nuclear reactor security in Europe. It also stopped in its tracks what had appeared to be a ‘nuclear renaissance’, both in Europe and globally, especially in the emerging countries. Under the accumulated pressure of rising demand and climate warming, many new nuclear projects had been proposed. Since 2011 there has been more ambivalence, especially in Europe. Some Member States have even decided to abandon the nuclear sector altogether. This Egmont Paper aims to examine the reactions of the EU regarding nuclear safety since 2011. Firstly, a general description of the nuclear sector in Europe is provided. The nuclear production of electricity currently employs around 500,000 people, including those working in the supply chain. It generates approximately €70 billion per year. It provides roughly 30% of the electricity consumed in the EU. At the end of 2013, there were 131 nuclear power reactors active in the EU, located in 14 countries. Four new reactors are under construction in France, Slovakia and Finland. Secondly, this paper will present the Euratom legal framework regarding nuclear safety. The European Atomic Energy Community (EAEC or Euratom) Treaty was signed in 1957, and somewhat obscured by the European Economic Community (EEC) Treaty. It was a more classical treaty, establishing institutions with limited powers. Its development remained relatively modest until the Chernobyl catastrophe, which provoked many initiatives. The most important was the final adoption of the Nuclear Safety Directive 2009/71. Thirdly, the general symbiosis between Euratom and the International Atomic Energy Agency (IAEA) will be explained. Fourthly, the paper analyses the initiatives taken by the EU in the wake of the Fukushima catastrophe. These initiatives are centred around the famous ‘stress tests’. Fifthly, the most important legal change brought about by this event was the revision of Directive 2009/71. Directive 2014/87 has been adopted quite rapidly, and has deepened in various ways the role of the EU in nuclear safety. It has reinforced the role and effective independence of the national regulatory authorities. It has enhanced transparency on nuclear safety matters. It has strengthened principles, and introduced new general nuclear safety objectives and requirements, addressing specific technical issues across the entire life cycle of nuclear installations, and in particular, nuclear power plants. It has extended monitoring and the exchange of experiences by establishing a European system of peer reviews. Finally, it has established a mechanism for developing EU-wide harmonized nuclear safety guidelines. In spite of these various improvements, Directive 2014/87 Euratom still reflects the ambiguity of the Euratom system in general, and especially in the field of nuclear safety. The use of nuclear energy remains controversial among Member States. Some of them remain adamantly in favour, others against or ambivalent. The intervention of the EAEC institutions remains sensitive. The use of the traditional Community method remains limited. The peer review method remains a very peculiar mechanism that deserves more attention.
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In December 2015, The Commission proposed to set up a European Border and Coast Guard (EBCG) as one of the key responses to the 2015 ‘refugee crisis’. The initiative intends to give Frontex, the EU’s current border agency, more competences, staff and equipment, and to rename it the EBCG. The new EBCG would work together with the member states’ national border and coast guard authorities.
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Mode of access: Internet.
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With cooperation of U. S. Department of Agriculture and land-grant colleges.
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"August 1995"--P. [4] of cover.
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There is international interest in Australia's health care system for prescription medicines. The issue is particularly topical in Canada with the debate following publication of the Romanow Report into the future of health care in Canada. This Report recommended a new National Drug Agency. Australia has a National Medicines Policy with four arms-quality, safety and efficacy of medicines; equity of access; a viable and responsible pharmaceutical industry; quality use of medicines. The four arms of the Policy are interlinked and interdependent for optimal functioning. In this paper, an overview of how the prescription drug system in Australia works is presented. The manuscript focuses upon specific aspects of the Policy, describing how it functions and some of the processes integral to success, from the viewpoint of the author. The discussion includes some of the advantages of Australia's system for pharmaceuticals as well as some of the problems, as these present opportunities for development and change
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The European Union institutions represent a complex setting and a specific case of institutional translation. The European Central Bank (ECB) is a particular context as the documents translated belong to the field of economics and, thus, contain many specialised terms and neologisms that pose challenges to translators. This study aims to investigate the translation practices at the ECB, and to analyse their effects on the translated texts. In order to illustrate the way texts are translated at the ECB, the thesis will focus on metaphorical expressions and the conceptual metaphors by which they are sanctioned. Metaphor is often associated with literature and less with specialised texts. However, according to Lakoff and Johnson’s (1980) conceptual metaphor theory, our conceptual system is fundamentally metaphorical in nature and metaphors are pervasive elements of thought and speech. The corpus compiled comprises economic documents translated at the ECB, mainly from English into Romanian. Using corpus analysis, the most salient metaphorical expressions were identified in the source and target texts and explained with reference to the main conceptual metaphors. Translation strategies are discussed on the basis of a comparison of the source and target texts. The text-based analysis is complemented by questionnaires distributed to translators, which give insights into the institution’s translation practices. As translation is an institutional process, translators have to follow certain guidelines and practices; these are discussed with reference to translators’ agency. A gap was identified in the field of institutional translation. The translation process in the EU institutions has been insufficiently explored, especially regarding the new languages of the European Union. By combining the analysis of the institutional practices, the texts produced in the institution and the translators’ work (by the questionnaires distributed to translators), this thesis intends to bring a contribution to institutional translation and metaphor translation, particularly regarding a new EU language, Romanian.
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There is an ongoing debate over the use of pharmaceutical excipients in medicines for children, triggered by the increased number of formulations suitable for this target patient population. Pharmaceutical excipients can be regarded as essential / necessary enablers in formulation development. These are materials other than the 'active pharmaceutical ingredient' which are added to the formulation to achieve a specific function1. This may include aiding in the processing or manufacture of the drug delivery system such as lubricants or flow aids, controlling the release of the active ingredient to achieve modified release, enhance patient acceptability by improving taste of medicines or to develop easily swallowed dosage forms.
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PHAR-QA, funded by the European Commission, is producing a framework of competences for pharmacy practice. The framework is in line with the EU directive on sectoral professions and takes into account the diversity of the pharmacy profession and the on-going changes in healthcare systems (with an increasingly important role for pharmacists), and in the pharmaceutical industry. PHAR-QA is asking academia, students and practicing pharmacists to rank competences required for practice. The results show that competences in the areas of drug interactions, need for drug treatment and provision of information and service were ranked highest whereas those in the areas of ability to design and conduct research and development and production of medicines were ranked lower. For the latter two categories, industrial pharmacists ranked them higher than did the other five groups
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To escape certain death during the Nazi regime, approximately eighty thousand terrorized and persecuted Eastern European Jews sought refuge in the forests surrounding their communities. Most often, their forest deaths were the result of Nazi-sponsored activities such as ghetto deportations and hunts for Jewish escapees. However, anti-Semitic partisans, partisan combat, hostile peasants, and environmental elements were also factors contributing to an estimated ninety percent fatality rate. This dissertation explored the role and meaning of forests to these Jewish fugitives. It investigated the bodily and social practices they developed to enhance their odds of survival in the forest landscape. I develop the concept of landscape agency as a response to my research question: What was it like to live and survive (or die) in the forest during the Holocaust? Moreover, it is an approach to theorizing about the humanity of space. Landscape agency builds upon a phenomenological approach to space and place that links landscape and action through bodily practices. This dissertation analyzed the fugitives' actions as functions of various forms of capital, namely economic, cultural and social. The sample included thirteen individuals who were themselves forest fugitives during the Holocaust. Face-face qualitative interviews were conducted from 2004 to 2006. Primary data from these interviews was used extensively to demonstrate the practices utilized in the fugitives' experiences with life and death in the forest. This study concluded that the odds of survival for forest fugitives were enhanced by use of landscape agency.
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The authors wish to acknowledge the valuable comments and suggestions made by members of the Committee of Fisheries of the European Parliament. The authors also thank the financial support of the European Parliament (IP/B/PECH/IC/2014–084) and the assistance of Ojama Priit and Marcus Brewer. SV acknowledges the financial support from the Spanish Agency for International Development Cooperation (AECID) (Grant no 11-CAP2–1406) and the Galician Government (Consellería de Cultura, Educación e Ordenación Universitaria, Xunta de Galicia) (Grant no R2014/023). MC acknowledges the financial support from the European Commission through the Marie Curie Career Integration Grant Fellowships – PCIG10-GA-2011–303534 - to the BIOWEB project. CP and GP acknowledge the financial support of Caixa Geral de Depósitos (Portugal) and the University of Aveiro. CP would also like to acknowledge FCT/MEC national funds and FEDER co-funding, within the PT2020 partnership Agreement and Compete 2020, for the financial support to CESAM (Grant no UID/AMB/50017/2013). JMDR and JGC thanks the financial support from the European Commission (MINOW H2020-SFS-2014–2, No 634495) and Xunta de Galicia (GRC 2015/014 and ECOBAS). MA acknowledges financial aid of Xunta de Galicia through Project GPC 2013–045. URS and CP acknowledge the Too Big to Ignore Partnership supported by the Social Sciences and Humanities Research Council of Canada (SSHRC).
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INTRODUCTION: The National Institute for Health and Clinical Excellence/National Patient Safety Agency (NICE/NPSA) guidelines for medicines reconciliation (MR) on admission to hospital in adult inpatients were introduced in 2007, but they excluded children less than 16 years of age. METHOD: We conducted a survey of 98 paediatric pharmacists (each from a different hospital) to find out what the current practice of MR in children is in the UK. KEY FINDINGS: Responses showed that 67% (43/64) of pharmacists surveyed carried out MR in all children at admission and only a third 34% (22/64) had policies for MR in children. Of the respondents who did not carry out MR in all children, 80% (4/5) responded that they did so in selected children. Pharmacists considered themselves the most appropriate profession for carrying out MR. When asked whether the NICE guidance should be expanded to include children, 98% (54/55) of the respondents answered 'yes'. CONCLUSION: In conclusion, the findings suggest that MR is being conducted inconsistently in children and most paediatric pharmacists would like national guidance to be expanded to include children.