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The Interplay Of Global Standards And Eu Pharmaceutical Regulation
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Book Synopsis The Interplay of Global Standards and EU Pharmaceutical Regulation by : Sabrina Röttger-Wirtz
Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Book Synopsis The Legitimacy of Standardisation as a Regulatory Technique by : Mariolina Eliantonio
Download or read book The Legitimacy of Standardisation as a Regulatory Technique written by Mariolina Eliantonio and published by Edward Elgar Publishing. This book was released on 2020-06-26 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book examines the field of European and global standardisation, showing how standards give rise to a multitude of different legal questions. It explores diverse topics in regulation such as food safety, accounting, telecommunications and medical devices. Each chapter offers in-depth analysis of a number of key policy areas. These multi-disciplinary contributions go beyond the field of law, and provide cross-disciplinary comparisons.
Book Synopsis The External Dimension of EU Agencies and Bodies by : Herwig C.H. Hofmann
Download or read book The External Dimension of EU Agencies and Bodies written by Herwig C.H. Hofmann and published by Edward Elgar Publishing. This book was released on 2019 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book addresses urgent questions about the external actions of the EU’s decentralized agencies and their effects, such as how they should be conceptualized and assessed, and how these agencies can and should be governed in the future. Bringing together pioneering interdisciplinary work from European legal and political scholars, the book combines theory with empirical case studies to explore an underdeveloped field and identify a future research agenda. p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 10.0px Arial}
Book Synopsis Competition and Patent Law in the Pharmaceutical Sector by : Giovanni Pitruzzella
Download or read book Competition and Patent Law in the Pharmaceutical Sector written by Giovanni Pitruzzella and published by Kluwer Law International. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Book Synopsis Leeway to Operate With Plant Genetic Resources by : Rodomiro Ortiz
Download or read book Leeway to Operate With Plant Genetic Resources written by Rodomiro Ortiz and published by Frontiers Media SA. This book was released on 2020-10-08 with total page 151 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.
Book Synopsis Global Regulatory Standards in Environmental and Health Disputes by : Caroline E. Foster
Download or read book Global Regulatory Standards in Environmental and Health Disputes written by Caroline E. Foster and published by Oxford University Press. This book was released on 2021 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global regulatory standards are emerging from the environmental and health jurisprudence of the International Court of Justice, the World Trade Organization, under the United Nations Convention on the Law of the Sea, and investor-state dispute settlement. Most prominent are the three standards of regulatory coherence, due regard for the rights of others, and due diligence in the prevention of harm. These global regulatory standards are a phenomenon of our times, representing a new contribution to the ordering of the relationship between domestic and international law, and a revised conception of sovereignty in an increasingly pluralistic global legal era. However, the legitimacy of the resulting 'standards-enriched' international law remains open to question. International courts and tribunals should not be the only fora in which these standards are elaborated, and many challenges and opportunities lie ahead in the ongoing development of global regulatory standards. Debate over whether regulatory coherence should go beyond reasonableness and rationality requirements and require proportionality stricto sensu in the relationship between regulatory measures and their objectives is central. Due regard, the most novel of the emerging standards, may help protect international law's legitimacy claims in the interim. Meanwhile, all actors should attend to the integration rather than the fragmentation of international law, and to changes in the status of private actors.
Book Synopsis International Regulatory Co-operation Addressing Global Challenges by : OECD
Download or read book International Regulatory Co-operation Addressing Global Challenges written by OECD and published by OECD Publishing. This book was released on 2013-05-31 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is becoming increasingly global. This raises challenges for regulatory processes which still largely emanate from domestic jurisdictions. Governments increasingly seek to better articulate regulations across borders and to ensure greater enforcement of rules.
Book Synopsis Global Business Regulation by : John Braithwaite
Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Author :Organization for Economic Cooperation and Development Publisher :Organization for Economic Co-Operation & Development ISBN 13 :9789264275935 Total Pages :0 pages Book Rating :4.2/5 (759 download)
Book Synopsis International Regulatory Co-operation and Trade by : Organization for Economic Cooperation and Development
Download or read book International Regulatory Co-operation and Trade written by Organization for Economic Cooperation and Development and published by Organization for Economic Co-Operation & Development. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory differences across jurisdictions can be costly for traders. While these costs may reflect variations in domestic conditions and preferences, they may also be the result of rule-making processes working in isolation and of a lack of consideration for the international environment. Thus, some of the trade costs of regulatory divergence may be avoided without compromising the quality of regulatory protection. Building on lessons learnt from OECD analytical work and the experiences of OECD countries in regulatory policy and trade, this report proposes a definition of trade costs of regulatory divergence and analyses various approaches to addressing them, including unilateral, bilateral and multilateral approaches. It focuses on the contribution of good regulatory practices, the adoption of international standards, and the use of cross-border recognition frameworks and trade agreements. Based on this, the report provides indications for policy makers on how to reduce trade costs through international regulatory co-operation.
Book Synopsis The Interplay Between Competition Law and Intellectual Property by : Gabriella Muscolo
Download or read book The Interplay Between Competition Law and Intellectual Property written by Gabriella Muscolo and published by Kluwer Law International B.V.. This book was released on 2019-01-17 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Book Synopsis Ensuring Quality to Gain Access to Global Markets by : Martin Kellermann
Download or read book Ensuring Quality to Gain Access to Global Markets written by Martin Kellermann and published by World Bank Publications. This book was released on 2019-04-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.
Author :Great Britain: Parliament: House of Commons: Health Committee Publisher :The Stationery Office ISBN 13 :9780215024572 Total Pages :556 pages Book Rating :4.0/5 (245 download)
Book Synopsis The Influence of the Pharmaceutical Industry by : Great Britain: Parliament: House of Commons: Health Committee
Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.
Book Synopsis WHO guideline on country pharmaceutical pricing policies by :
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Book Synopsis Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by : OECD
Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Book Synopsis European Drug Prevention Quality Standards by :
Download or read book European Drug Prevention Quality Standards written by and published by . This book was released on 2011 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The European Fund for Strategic Investments: The Legacy by : European Investment Bank
Download or read book The European Fund for Strategic Investments: The Legacy written by European Investment Bank and published by European Investment Bank. This book was released on 2021-01-07 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inside story of the European Fund for Strategic Investments from 2015 to 2020 told through interviews with the Managing Director, Deputy Managing Director, members of the Investment Committee and final beneficiaries across Europe. The architects of this €500 billion-plus programme, the head of the EU bank and the president of the European Commission, describe the genesis of this financial pillar of the Investment Plan for Europe. Then the people who ran one of the biggest economic stimulus programmes in history detail how they did it—and what the lessons are for policymakers responding to new crises, including the economic shock caused by the COVID-19 pandemic. The European Fund for Strategic Investments has been one of the good news stories to emerge in a decade of economic uncertainty. It has gone well beyond its highly ambitious target of €500 billion in mobilised investments. The Juncker Plan has made a strong contribution to the 14 million jobs created in the EU between 2015 and 2020. It has become a success in co-financing projects that otherwise might not have been carried through. It has also charted the path towards new ways of financing. This is not only the case in relatively conventional areas, such as infrastructure, but also in sectors like research and innovation or the contribution to climate change mitigation. This is exactly what makes EFSI so ground-breaking: responding to the needs of the market through continuous financial innovation. The principle of the European Fund for Strategic Investments is here to stay. It has paved the way for its successor, the InvestEU programme, which is to be deployed under the 2021-2027 multiannual financial framework. This publication details why the programme was such a success.
Book Synopsis The European Union as a Global Regulator? by : Alasdair Young
Download or read book The European Union as a Global Regulator? written by Alasdair Young and published by Routledge. This book was released on 2017-10-02 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Union is often depicted as a dominant global regulator. The purpose of this volume is to move beyond establishing that the EU influences global regulation to being to identify under what conditions it exerts that influence. Toward that end, it focuses on the EU's active efforts, both bilateral and multilateral, to shape regulations beyond its borders. The empirical chapters in this volume are explicitly comparative, among foreign partners, across international contexts, over time, and across issues. The more conceptual contributions posit an explanation for the EU’s choice of regulatory cooperation strategy and take stock of Market Power Europe as a dynamic conceptual framework for understanding and researching the EU as a power. Collectively, this volume advances three arguments: the utility of the EU’s regulatory power resources is context specific; debates about what kind of power the EU is, at least as currently conceived, are unproductive; and that the EU’s engagement in the world is better explained through general theories of international political economy. This book was published as a special issue of the Journal of European Public Policy.
