This book demonstrates how the Thalidomide catastrophe of the 1960s and the BSE crisis of the 1990s led to regulatory regimes for pharmaceuticals and foodstuffs in Europe. This collection analyses European law and its relationships with new health technologies. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand ... Found insideBased on the 2014 O’Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. This handbook offers an up-to-date analytical overview of the most important topics in EU health law and policy. It outlines, as far as possible, the direction of travel for each topic and suggests research agenda(s) for the future. Essay from the year 2004 in the subject Medicine - Other, grade: good, Anglia Ruskin University, 10 entries in the bibliography, language: English, abstract: In 2001, when the Clinical Trial Directive 2001/20/EG was released in the European ... Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Drawing together an international and multidisciplinary selection of experts, this volume is an important contribution for all those interested in public health policy, EU health policy and EU governance. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. This book presents some of the latest developments in the world of rare disease entrepreneurship from a global group of experts. Found insideTo guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. This volume considers the ethical challenges of research with minors for the researchers, but also for the involved research ethics committees. This is a comprehensive volume covering the processes by which medicines are developed, tested and approved. The book thus offers a comprehensive discussion of a number of current and emerging governance issues in EU health policy, including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal framework ... Found insideKey Features: 800 signed articles, authored by prominent scholars, are arranged A-to-Z and published in a choice of electronic or print formats Although arranged A-to-Z, a Reader's Guide in the front matter groups articles by thematic areas ... Medicine Price Surveys, Analyses and Comparisons establishes guidelines for the study and implementation of pharmaceutical price surveys, analyses, and comparisons. This insightful text offers an in depth perspective of the policies and the debates that surround them. Chapters are well-referenced and many include helpful figures and tables to illustrate facts and ideas. This report sets out the background to the proposals in detail that the European Commission has put forward about the free movement of medicinal products in the Community and the opinion of the Committee. At the same time, this development has significantly affected regulatory policy-making in the EU. This volume assembles the most renowned scholars in the field to address the key themes and challenges that agency governance in the EU poses ... Although this is a major issue of concern, systematic empirical research into the topic is lacking. This book addresses empirically whether, and if so on what counts, agency accountability is problematic. This book examines regulatory capacity beyond the nation state. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical ... This volume presents the viewpoints of academics, food lawyers, industry and consumer representatives as well as those of EU policymakers on the first ten years of activity of one of the most prominent European agencies. Found insideRegulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. They aim to provide expert advice independent of political or economic considerations. This book explains whether and under what conditions ERAs comply with this scientific mandate. Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. 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