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Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
ISBN: 1509943005
Category : Law
Languages : en
Pages : 417
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Book Description
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.
Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
ISBN: 1509943005
Category : Law
Languages : en
Pages : 417
Get Book Here
Book Description
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.
Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
ISBN: 1509942998
Category : Law
Languages : en
Pages : 251
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Book Description
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.
Author: Herwig C.H. Hofmann
Publisher: Edward Elgar Publishing
ISBN: 1788973755
Category : Political Science
Languages : en
Pages : 245
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Book Description
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}
Author: Mariolina Eliantonio
Publisher: Edward Elgar Publishing
ISBN: 1789902959
Category : Law
Languages : en
Pages : 315
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Book Description
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.
Author: Tamara Hervey
Publisher: Bloomsbury Publishing
ISBN: 1509951504
Category : Law
Languages : en
Pages : 279
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Book Description
What does the UK's exit from the EU mean for health and the NHS? This book explains the legal and practical implications of Brexit on the NHS: its staffing; especially on the island of Ireland; medicines, medical devices and equipment; and biomedical research. It considers the UK's post-Brexit trade agreements and what they mean for health, and discusses the effects of the COVID-19 pandemic on post-Brexit health law. To put the legal analysis in context, the book draws on over 400 conversations the authors had with people in the north of England and Northern Ireland, interviews with over 40 health policy stakeholders, details of a film about their research made with ShoutOut UK, the authors' work with Parliaments and governments across the UK, and their collaborations with key actors like the NHS Confederation, the British Medical Association, and Cancer Research UK. The book shows that the language people use to talk about hoped-for legitimate post-Brexit health governance suggests a great deal of faith in law and legal process among 'ordinary people', but the opposite from 'insider elites'. Not What The Bus Promised puts the authors' knowledge and experiences centre frame, rather than claiming to express 'objective reality'. It will be of interest to any reader who cares about the NHS and wants to understand its present and future.
Author: Theodosia Stavroulaki
Publisher: Bloomsbury Publishing
ISBN: 1509943358
Category : Law
Languages : en
Pages : 291
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Book Description
Market driven healthcare is massively divisive. Opponents argue that a competition approach to medical treatment negatively impacts on quality, while advocates point to increased efficiencies. This book casts a critical eye over both positions to show that the concerns over quality are in fact real. Taking a two part approach, it unveils the fault lines along which healthcare provision and the pursuit of quality would in certain cases clash. It then shows how competition authorities can only effectively assess competition concerns when they ask the fundamental question of how the concept of healthcare quality should be defined and factored into their decisions. Drawing on UK, US and EU examples, it explores antitrust and merger cases in hospital, medical and health insurance markets to give an accurate depiction of the reality and challenges of regulating competition in healthcare provision.
Author: Wael Mohamed
Publisher: CRC Press
ISBN: 1040115896
Category : Science
Languages : en
Pages : 315
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Book Description
The increasing demand for innovative techniques arises from the lack of safe, effective, and patient-friendly therapies for neurodegenerative disorders. With this objective in mind, the chapters of the book are structured to offer a thorough insight into recent advancements in utilizing the zebrafish (ZF) as a model for studying Parkinson’s disease (PD). This book aims to present readers with a comprehensive understanding of the clinical application of the ZF model in treating PD, encompassing the latest developments, challenges, safety considerations, toxicity issues, regulatory aspects, future potential, and limitations. Individuals in academia, the scientific community, business, and education seeking a more effective approach to target the brain stand to benefit from this resource. Key Features Provides a comparative perspective of the zebrafish–Parkinson’s disease model Highlights the restrictions of available medicines Describes biochemical and histopathological characteristics, advantages, and disadvantages of this model Emphasizes distinct facets of histopathology Presents advances and developments of the future potential perspectives
Author: Kornilia Pipidi-Kalogirou
Publisher: Springer Nature
ISBN: 303171900X
Category :
Languages : en
Pages : 248
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Book Description
Author: Rodomiro Ortiz
Publisher: Frontiers Media SA
ISBN: 2889660087
Category : Nature
Languages : en
Pages : 151
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Book Description
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: John Braithwaite
Publisher: Cambridge University Press
ISBN: 9780521780339
Category : Business & Economics
Languages : en
Pages : 194
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Book Description
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.
