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Pharmaceutical Medicine Biotechnology And European Law
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Book Synopsis Pharmaceutical Medicine, Biotechnology and European Law by : Richard Goldberg
Download or read book Pharmaceutical Medicine, Biotechnology and European Law written by Richard Goldberg and published by Cambridge University Press. This book was released on 2000 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Book Synopsis The Business of Healthcare Innovation by : Lawton Robert Burns
Download or read book The Business of Healthcare Innovation written by Lawton Robert Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.
Book Synopsis Pharmaceutical Biotechnology by : Oliver Kayser
Download or read book Pharmaceutical Biotechnology written by Oliver Kayser and published by John Wiley & Sons. This book was released on 2012-05-21 with total page 677 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Assuring the Quality of Health Care in the European Union by : Helena Legido-Quigley
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Book Synopsis Research Handbook on EU Health Law and Policy by : Tamara K. Hervey
Download or read book Research Handbook on EU Health Law and Policy written by Tamara K. Hervey and published by Edward Elgar Publishing. This book was released on 2017-03-31 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: The steady expansion of the European Union’s involvement in health over the past 20 years has been accelerated by recent events. 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.
Book Synopsis The Law of Off-label Uses of Medicines by : Andrea Parziale
Download or read book The Law of Off-label Uses of Medicines written by Andrea Parziale and published by Taylor & Francis. This book was released on 2022-08-12 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Book Synopsis Health Law and the European Union by : Tamara K. Hervey
Download or read book Health Law and the European Union written by Tamara K. Hervey and published by Cambridge University Press. This book was released on 2004-11-04 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: How does the law of the European Union affect health law and policy? At first sight, it seems limited. However, despite its restricted formal competence, the EU has recently become increasingly involved in the health field. Litigation based on EU law has resulted in a 'right to receive health care services' across national boundaries which may have huge practical implications for national health systems. The EU has promulgated legislation regulating clinical research, and the marketing of pharmaceuticals; patients' rights are affected by EU legislation on data protection and product liability; the qualifications of health care professionals are legally recognised across the EU; and the EU has acted to promote public health. This book explores the various impacts of measures of EU law on national health law and policy. Through elaboration of selected examples, the authors show that, within the EU, health law cannot be regarded as a purely national affair.
Book Synopsis Private Law in the External Relations of the EU by : Marise Cremona
Download or read book Private Law in the External Relations of the EU written by Marise Cremona and published by Oxford University Press. This book was released on 2016 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: An edited volume exploring the interaction between EU external relations law and private law, examining how the relationship has affected the evolution of the EU's competence, the extent of EU private law's reach beyond the boundaries of an internal market, and how the EU contributes to the formation of private regulation at an international level.
Book Synopsis Foundations of EU Food Law and Policy by : Alberto Alemanno
Download or read book Foundations of EU Food Law and Policy written by Alberto Alemanno and published by Routledge. This book was released on 2016-04-15 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Its broader purpose, however, is to discuss the future role played by EFSA within the rapidly-evolving area of EU food law and policy. By revisiting and discussing the milestones in the history of EFSA, the collection provides forward-looking views of food leaders and practitioners on the future scientific and regulatory challenges facing the European Union. In particular, by presenting a critical assessment of the agency’s activities within its different areas of work, the book offers readers a set of innovative tools for evaluating policy recommendations and better equips experts and the public to address pressing regulatory issues in this emotive area of law and policy. Despite its celebratory mood, the book’s focus is more about the future than the past of EU food law and policy. Each chapter discusses how EFSA’s role has evolved and identifies what it should have done differently while presenting an overall assessment of how the agency has discharged its mandate.
Book Synopsis Medicinal Product Liability and Regulation by : Richard Goldberg
Download or read book Medicinal Product Liability and Regulation written by Richard Goldberg and published by A&C Black. This book was released on 2014-07-18 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The piecemeal developments in product liability reform in Europe have their origins in the tragic association of phocomelia in children with thalidomide in 1962. In many ways these events have continued to generate pressure for reform of product liability, especially for the victims of drug-induced injury. This monograph attempts to address the major problems that typify claims for drug-induced injury, as well as highlighting the complex interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability under the product liability directive, the claimant may have considerable difficulty in establishing that the relevant product is defective and that it caused the damage. It may also be necessary to overcome the development risk defence where this is pleaded. The monograph addresses these problems on a comparative jurisprudential basis, and seeks to determine whether medicinal products should be treated as a special case in the field of product liability. It examines the role of epidemiological evidence in assessing causation in product liability cases concerning medicinal products in the light of recent developments in the UK Supreme Court, the United States, Canada and France. In particular, it addresses the difficulties in reconciling the standards of proof in law and science, including the theory that causation can be proved on the balance of probabilities by reference to the doubling of risk of injury. An important case study compares and contrasts the approaches of the UK and the US to the measles, mumps, rubella Litigation. The book also examines the question as to whether compliance with regulatory standards should protect pharmaceutical manufacturers from product liability suits. It seeks to support a via media whereby the victims of drug induced injury can receive justice, while at the same time encouraging drug safety and innovation in drug development.
Book Synopsis European Union Health Law by : Tamara K. Hervey
Download or read book European Union Health Law written by Tamara K. Hervey and published by Cambridge University Press. This book was released on 2015-11-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: A contextual analysis of the internal logics of EU health law through four themes: consumerism; (human) rights; interactions between equality, solidarity and competition; and risk. Leading authors in the emergent field explain the interactions and implications of EU health law through thematic reinterpretation of the law in context in key substantive areas, such as the regulation of health research, access of patients to high quality care, health care professional regulation, organisation and funding of health care services, and public health. This book offers a fresh perspective and thorough understanding of EU health law through individual and collective or systemic perspectives, and covers health law both within the EU and globally. Essential reading for anyone interested in health law in any EU Member State or in global health law.
Book Synopsis Pharmaceutical Innovation, Competition and Patent Law by : Josef Drexl
Download or read book Pharmaceutical Innovation, Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Book Synopsis Pharmaceutical Biotechnology by : Gary Walsh
Download or read book Pharmaceutical Biotechnology written by Gary Walsh and published by John Wiley & Sons. This book was released on 2007-08-13 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed
Book Synopsis Intellectual Property, Medicine and Health by : Johanna Gibson
Download or read book Intellectual Property, Medicine and Health written by Johanna Gibson and published by Routledge. This book was released on 2017-05-15 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intellectual Property, Medicine and Health examines critical issues and debates including access to knowledge and medicinal products, human rights and development, innovations in life technologies and the possibility for ethical frameworks for intellectual property law and its application in public health. The central question of trust and the beneficial interests of society in the use of products of intellectual property, particularly in the fulfillment of the right to access medicinal products, emerge as key to achieving meaningful access to knowledge in health and medicine and the realization of relevant and equitable use of the benefits of scientific research in all societies.
Book Synopsis European Union Law for the Twenty-First Century: Volume 2 by : Takis Tridimas
Download or read book European Union Law for the Twenty-First Century: Volume 2 written by Takis Tridimas and published by Bloomsbury Publishing. This book was released on 2004-12-06 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book, to be published in two volumes, is based on the contributions made to the W.G. Hart Workshop 2003. It contains more than forty contributions by leading experts seeking to assess the state of development of EU law some fifty years after the establishment of the Communities and contribute to the current debate on the European Constitution. The second volume focuses on challenges in the field of the internal market and external relations, looking at diverse areas of European Law, including free movement, competition law and merger control, public procurement, consumer law, enlargement, WTO, third country nationals, sex equality ets. Authors include: Tony Arnull, George Bermann, Marise Cremona, Paul Craig, Eileen Denza, Piet Eeckhout, Koen Lenaerts, Steve Peers, Wulf-Henning Roth, Francis Snyder, Erika Szyszczak, Takis Tridimas and Stephen Weatherill.
