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Author : Martin M. Shapiro
Publisher :
ISBN 13 :
Total Pages : 36 pages
Book Rating : 4.F/5 ( download)
Download or read book Integrating Scientific Expertise Into Regulatory Decision-making written by Martin M. Shapiro and published by . This book was released on 1996 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Olivier Godard
Publisher :
ISBN 13 :
Total Pages : 60 pages
Book Rating : 4.F/5 ( download)
Download or read book Integrating Scientific Expertise Into Regulatory Decision-making written by Olivier Godard and published by . This book was released on 1996 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Robert Hankin
Publisher :
ISBN 13 :
Total Pages : 44 pages
Book Rating : 4.F/5 ( download)
Download or read book Integrating Scientific Expertise Into Regulatory Decision-making written by Robert Hankin and published by . This book was released on 1996 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Josef Falke
Publisher :
ISBN 13 :
Total Pages : 72 pages
Book Rating : 4.F/5 ( download)
Download or read book Integrating Scientific Expertise Into Regulatory Decision-making written by Josef Falke and published by . This book was released on 1996 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recoge: 1. The new approach to technical harmonization and standards -- 2. New structures of the european and of the national standariztion -- 3. Reference to technical rules -- 4. Conclusions.
Author : Jens Rasmussen
Publisher :
ISBN 13 :
Total Pages : 56 pages
Book Rating : 4.F/5 ( download)
Download or read book Integrating Scientific Expertise Into Regulatory Decision-making written by Jens Rasmussen and published by . This book was released on 1996 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Download or read book Integrating Scientific Expertise Into Regulatory Decision-making written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Martinus Nijhoff Publishers
ISBN 13 : 9004233938
Total Pages : 322 pages
Book Rating : 4.0/5 (42 download)
Download or read book Regulatory Hybridization in the Transnational Sphere written by and published by Martinus Nijhoff Publishers. This book was released on 2013-03-27 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hybridization has become a defining feature of regulatory frameworks. The combined forces of globalization and privatization together with increased reliance on self-regulation have resulted in the emergence of a multitude of regulatory arrangements which combine elements from several legal orders. This book offers a conceptual framework as well as numerous empirical explorations capable of increasing our understanding of regulatory hybridization. A number of central dichotomies are deconstructed: national vs. transnational law; international vs. transnational law; convergence vs. divergence; soft law vs. hard law; territorial vs. non-territorial, ‘top-down’ vs. ‘bottom-up’ globalization and national vs. global just as the implications of regulatory hybridization for the question of choice of court and conflict of laws are analyzed. Contributors include: Poul Fritz Kjaer, Ino Augsberg, Jan Klabbers, Peer Zumbansen, Paulius Jurčys, Faye Fangfei Wang, Hideaki Shiroyama, Mark D. Fenwick, Nina Boerger, Joseph Corkin, Harm Schepel, Andreas Maurer, Adeline Chong, Ren Yatsunami, and Maebh Harding.
Author : Michelle Egan
Publisher : OUP Oxford
ISBN 13 : 0191529524
Total Pages : 382 pages
Book Rating : 4.1/5 (915 download)
Download or read book Constructing a European Market written by Michelle Egan and published by OUP Oxford. This book was released on 2001-06-14 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Efforts to tackle the trade impeding effects of divergent standards and regulations are at the core of European economic relations. This volume draws on literature from several disciplines to develop a comprehensive account of the regulatory strategies and institutional arrangements adopted by the EU in promoting the single market in goods. It provides a historical overview and detailed cases studies of the various policy initiatives that have altered the boundaries between the public and private sector in fostering market integration. Tackling interstate barriers to trade has relied heavily on European law to shape the framework of relations between states, and trade liberalization has been facilitated by legal rulings resolving territorial conflicts over regulatory jurisdiction and authority. The European Court of Justice has actively shaped markets, acting as a 'free trade umpire' in balancing the goals of market liberalization and market regulation while fostering market compliance. Although markets are absolutely dependent on public authority, the institutional innovation of the EU has been to use the private sector in an ancillary role to the state. By delegating responsibility to set standards for market access, the EU has chosen to draw on the resources of private actors, resulting in a system of governance that is a distinctive, hybrid model of regulation composed of state and non-state actors. Though the "outsourcing" of public sector regulatory activity was expected to be more effective than the process of regulatory harmonization, progress has been difficult. The current deficit in setting standards for European-wide market access raises concerns about the efficiency and effectiveness of such a regulatory regime. Egan provides a detailed evaluation of that process, highlighting regulatory gaps in the single market and the need to focus not only on the process of market integration, but also its outcome and impact on European business. Comparisons with American efforts to create a national market are made throughout to demonstrate the difficulties of constructing and maintaining a single market. American and European efforts to devise a uniform market for commerce and trade have involved both public and private authorities, though with different degrees of coordination and centralization, as many of the strategies undertaken by the EU echo earlier American market-building efforts.
Author : Marjolein van Asselt
Publisher : Routledge
ISBN 13 : 1134595654
Total Pages : 289 pages
Book Rating : 4.1/5 (345 download)
Download or read book Trade, Health and the Environment written by Marjolein van Asselt and published by Routledge. This book was released on 2013-10-30 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: The trade conflicts that the EU has faced within the EU or WTO context demonstrate that the question of how to balance trade and other societal values in situations of uncertainty has not been solved by the regulatory model evolved by the EU in the aftermath of the BSE crisis – one which privileges processes of depoliticisation and scientification. This book addresses the current key dilemmas around science, law and the regulation of trade, both on a regime level and in the context of particular industrial sectors, e.g pharmaceuticals, climate change and nanotechnology. It will present possible future research avenues by looking at both theory and practice and learning from various disciplines (law and social sciences), legal realities (WTO, USA and EU) and actors (regulators, stakeholders, courts).
Author : Andrew F. Roberts
Publisher : Frontiers Media SA
ISBN 13 : 2889660338
Total Pages : 252 pages
Book Rating : 4.8/5 (896 download)
Download or read book Biosafety of Genetically Modified Organisms, Volume II written by Andrew F. Roberts and published by Frontiers Media SA. This book was released on 2020-10-27 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact.
Author : Christian Joerges
Publisher : Bloomsbury Publishing
ISBN 13 : 1509926976
Total Pages : 619 pages
Book Rating : 4.5/5 (99 download)
Download or read book Conflict and Transformation written by Christian Joerges and published by Bloomsbury Publishing. This book was released on 2022-10-06 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this important compendium, one of the leading scholars of EU law and its legal framework, reflects on his previous writings in the context of current challenges the European project is facing. More than a simple restatement, it offers an important theoretical comment at this defining time for EU law. The author offers a welcome counterbalance to what some perceive to be a surfeit of optimism when assessing the EU and its development. In so doing, Professor Joerges identifies three flaws in the current European ideology. Firstly, he points to the intellectual weakness of the “integration through law” ideology. Secondly, the book sets out the systematic neglect of “the economic” and its political dynamics. Finally, it addresses the complacency with respect to Europe's darker legacies. This is an important critical (and candid) assessment of Europe at its half century.
Author : Geert van Calster
Publisher : Edward Elgar Publishing
ISBN 13 : 1781006148
Total Pages : 881 pages
Book Rating : 4.7/5 (81 download)
Download or read book Research Handbook on Environment, Health and the WTO written by Geert van Calster and published by Edward Elgar Publishing. This book was released on 2013 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: ÔThis edited collection brings together an impressive array of authors from the world of international trade, the environment and public health. Each of them is eminently well-placed to bring their own particular expertise to bear on the issue at hand, and to do so in a knowledgeable and stimulating manner. This Research Handbook is a must for anyone interested in these overlapping fields of law and policy whether as a basis for learning or as a resource for further research.Õ Ð Mary Footer, University of Nottingham School of Law, UK ÔThis fantastic collection of essays explores the multiple intersections between trade and environment in the WTO. The contributions by leading scholars are theoretically engaged whilst practical in their focus. It is a Òmust readÓ for those concerned to ensure that trade liberalisation does not stand in the way of sustainable development, including urgently needed action to mitigate the risks and consequences of climate change.Õ Ð Joanne Scott, University College London, UK ÔGeert Van Calster and Denise PrŽvost have managed to induce virtually all the great experts on health, environment and WTO law to contribute to their Research Handbook on these subjects. The result is undoubtedly an excellent volume that should adorn the bookcase of any and all interested in the important problem of the relation between international rule-making and regulatory autonomy of states in this area of international economic law.Õ Ð Pieter Jan Kuijper, University of Amsterdam, The Netherlands This Handbook provides state-of-the-art analysis by leading authors on the links between the international trade regime and health and environment concerns Ð concerns that make up an increasing proportion of WTO dispute settlement. Research Handbook on Environment, Health and the WTO surveys fields as diverse as climate change mitigation, non-communicable diseases, nanotechnology and public health care. The volume brings to the fore the debates and complexities surrounding these issues and their implications for the international trading system. The Handbook begins in Part I with a survey of general issues that sets a context for the more specific sectorial studies. Part II considers the most pressing issues within health regulation and trade law, whilst Part III is devoted to environmental regulation and its interface with trade law. Part IV looks specifically at aspects of the dispute settlement process and in particular standard of review, and the book concludes in Part V with a consideration of the impact of trade measures on the health and environment regimes of emerging economies. This comprehensive yet concise Handbook will appeal to academics and researchers in international trade law and environmental law, as well as trade law practitioners.
Author : Christian Joerges
Publisher : Bloomsbury Publishing
ISBN 13 : 1847312861
Total Pages : 592 pages
Book Rating : 4.8/5 (473 download)
Download or read book Constitutionalism, Multilevel Trade Governance and Social Regulation written by Christian Joerges and published by Bloomsbury Publishing. This book was released on 2006-10-19 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a book about the ever more complex legal networks of transnational economic governance structures and their legitimacy problems. It takes up the challenge of the editors' earlier pioneering works which have called for more cross-sectoral and interdisciplinary analyses by scholars of international law, European and international economic law, private international law, international relations theory and social philosophy to examine the interdependences of multilevel governance in transnational economic, social, environmental and legal relations. Two complementary strands of theorising are expounded. One argues that globalisation and the universal recognition of human rights are transforming the intergovernmental "society of states" into a cosmopolitan community of citizens which requires more effective constitutional safeguards for protecting human rights and consumer welfare in the national and international governance and legal regulation of international trade. The second emphasises the dependence of the functioning of international markets and liberal trade on governance arrangements which respond credibly to safety and environmental concerns of consumers, traders, political and non-governmental actors. Enquiries into the generation of international standards and empirical analyses of legalization and judizialisation practices form part of this agenda. The perspectives and conclusions of the more than 20 contributors from Europe and North-America cannot be uniform. But they converge in their search for a constitutional architecture which limits, empowers and legitimises multilevel trade governance, as well as in their common premise that respect for human rights, private and democratic self-government and social justice require more transparent, participatory and deliberative forms of transnational "cosmopolitan democracy".
Author : Jacqueline Peel
Publisher : Federation Press
ISBN 13 : 9781862875197
Total Pages : 260 pages
Book Rating : 4.8/5 (751 download)
Download or read book The Precautionary Principle in Practice written by Jacqueline Peel and published by Federation Press. This book was released on 2005 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: The precautionary principle puts forward the 'commonsense' notion that decision-makers should be cautious when assessing potential health or environmental harms in the absence of the full scientific facts. It is now a well-established tenet of environmental law. The debate has turned to its legal implementation, especially its application 'in practice'. The Precautionary Principle in Practice - Environmental decision-making and scientific uncertainty focuses on these issues. It considers how decision-makers can assess threats to health or the environment when the available scientific evidence is sparse and discusses the types of 'uncertainties' that bring the precautionary principle into play.Peel uses detailed case studies which examine the implementation of the precautionary principle in actual decision-making scenarios: fisheries management; risk assessment for genetically modified organisms; and environmental impact assessment for development applications. She demonstrates an approach that takes account of variable uncertainty issues and can be adapted to different circumstances to ensure a comprehensive assessment of the potential threats to health or the environment. Jackie Peel has a background in both science and law. She took a BSC/LLB with 1st class honours at the University of Queensland and holds an LLM from New York University where she studied in 1999-2000 as a Fulbright Scholar. She is now is a Senior Lecturer in the Faculty of Law, University of Melbourne.
Author : Erik Oddvar Eriksen
Publisher : Routledge
ISBN 13 : 113458993X
Total Pages : 325 pages
Book Rating : 4.1/5 (345 download)
Download or read book Democracy in the European Union written by Erik Oddvar Eriksen and published by Routledge. This book was released on 2002-09-11 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Union is widely held to suffer from a democratic deficit, and this raises a wider question: can democracy at all be applied to decision-making bodies beyond the nation state? Today, the EU is a highly complex entity undergoing profound changes. This book asks how the type of cooperation that the EU is based on can be explained; what are the integrative forces in the EU and how can integration at a supra-national level come about? The key thinkers represented in this volume stress that in order to understand integration beyond the nation state, we need new explanatory categories associated with deliberation because a supranational entity as the EU posesses far weaker and less well-developed means of coercion - bargaining resources - than do states. The most appropriate term to denote this is the notion of 'deliberative supranationalism'. This pioneering work, headed by major writers such as Habermas, Schlesinger and Bellamy, brings a new perspective to this key issue in contemporary politics and political theory.
Author : Giandomenico Majone
Publisher : OUP Oxford
ISBN 13 : 0191534390
Total Pages : 256 pages
Book Rating : 4.1/5 (915 download)
Download or read book Dilemmas of European Integration written by Giandomenico Majone and published by OUP Oxford. This book was released on 2005-03-24 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: If one lesson emerges clearly from fifty years of European integration it is that political aims should be pursued by overtly political means, and not by roundabout economic or legal strategies. The functionalist strategy of promoting spillovers from one economic sector to another has failed to achieve a steady progress towards a federal union, as Jean Monnet and other functionalists had hoped. On the other hand, the unanticipated results of 'integration through law' have included over-regulation and an institutional framework which is too rigid to allow significant policy and institutional innovations. Thus, integration by stealth has produced sub-optimal policies and a steady loss of legitimacy by the supranational institutions. Both the functionalist approach and the classic Community Method are becoming obsolete. This major new statement from a leading European scholar provides the most thorough analysis currently available of the pitfalls and ambiguities of 50 years of European integration, without losing sight of its benefits. Majone provides a clear demonstration of how a number of European policies - including environmental protection - lack a logically defensible rationale, while showing how, in other cases, objectives may be better achieved by re-nationalizing the policy in question. He also shows how, in an information-rich environment, co-ordination by mutual adjustment becomes possible, meaning that member states are no longer as dependent on central institutions as in the past. He explains how the challenge for future research is to investigate methods-other than delegation to supranational institutions-by which member states can credibly commit themselves to collective action. Dilemmas of European Integration concludes by explaining exactly why the model of a United States of Europe is bound to fail-not just due to lack of popular support, but because it finds itself unable to deliver the public goods which Europeans expect to receive from a full fledged government. Although failing as a would-be federation, the present Union could become an effective confederation, built on the solid foundation of market integration. The new Constitutional Treaty, Majone argues, seems to point in this direction.
