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.

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}

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.

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

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.

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.

International institutions and the consequences of their interplay are emerging as a major agenda item for research and policy. As governments enter into an ever-increasing number of international agreements, questions arise about the overlap of issues, jurisdiction and membership. Of particular interest to practitioners and analysts is how this mélange of institutions at the international level intersects and interrelates to influence and affect the content, operation, performance and effectiveness of a specific institution, as well as the functioning of the overall global governance context. Biosafety, an issue relevant to numerous institutions, offers a case study for exploring and applying interplay in practical terms.--Publisher's description.