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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 Pharmaceuticals, Biotechnology and the Law by : Trevor Bird & Bird LLP
Download or read book Pharmaceuticals, Biotechnology and the Law written by Trevor Bird & Bird LLP and published by Springer. This book was released on 1991-12-12 with total page 845 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cook written by Trevor Cook and published by . This book was released on 2015-10-16 with total page 925 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.Written by leading patent and regulatory lawyer (Trevor Cook, WilmerHale), this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.The new edition examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.
Book Synopsis Biotechnology and the Law by : Hugh B. Wellons
Download or read book Biotechnology and the Law written by Hugh B. Wellons and published by American Bar Association. This book was released on 2007 with total page 1016 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
Book Synopsis Pharmaceuticals Biotechnology and the Law by : Trevor M. Cook
Download or read book Pharmaceuticals Biotechnology and the Law written by Trevor M. Cook and published by Butterworth-Heinemann. This book was released on 2009 with total page 925 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.Written by one of the country's leading patent and regulatory lawyers (Trevor Cook, Bird & Bird), this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.The book examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.The book has been comprehensively updated if not re-written to take account of the enormous amount of development in the field since publication of the first edition in 1991.Virtually every single regulatory framework addressed is completely new or radically updated since then and, for example, only two of the materials in the appendix date back to the first edition (e.g., pricing transparency and contained use).Entire areas of law have developed since then, such as regulatory data, which is accorded three chapters of coverage within the book. The field has also seen the introduction of the EPC 2000, the Biotechnology Directive and the maturing of biotechnology patenting, which was in its infancy at the time of the first edition. From these developments has come a raft of case law which is cross-referred to throughout.
Book Synopsis Key Issues in Pharmaceuticals Law by : José Luis Valverde
Download or read book Key Issues in Pharmaceuticals Law written by José Luis Valverde and published by IOS Press. This book was released on 2007 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The focus of Key Issues in Pharmaceuticals Law is on the ongoing achievement of an authentic world code for medicinal products - a so-called "Pharmacopoeia"--Through scientific technical harmonization. The legal dimension of medicinal products conditions the whole sector and it acquires a global dimension through the demand to protect people's health. Hence it is necessary to go forward to total harmonization of all its aspects. A global legal statute for medicinal products is justified by the very nature of the product, by its social control and the need for it to circulate freely, although limitations can be accepted, for reasons of solidarity with less favored populations. Awareness must arise that the challenge for healthcare is not going to find an adequate answer at the world level without a qualitative change in the world organization of the UN. The globalized world we live in demands reinforced continental solidarity, if we are to confront the common problems and bring about international order. A scientific technical code on the quality of medicinal products is essential for a statute on medicines. That code is the Pharmacopoeia."--Publisher.
Book Synopsis The Problem of Herbal Medicines Legal Status by : José Luis Valverde
Download or read book The Problem of Herbal Medicines Legal Status written by José Luis Valverde and published by IOS Press. This book was released on 1999 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: The main problem in the use of medicinal plants, discussed in this book, is that citizens are being persuaded that herbal medicine is based on its low or even absent toxicology. A good efficacy is assumed as self-evident, and therapeutic benefit without risks is expected. Many users prefer natural medicine instead of synthetic remedies. However, the number of reports on unwanted side effects of phytomedicines increased in the last years. In some instances, a lack of pharmaceutical quality was found. The unqualified recommendation of herbal medicines may represent a considerable risk to the user. The use of a herbal remedy with unproven efficacy can represent a risk for the user when a more effective and necessary treatment will therefore be stopped or omitted. These circumstances must be taken into account by the governments, inspection services, the doctors and the judges. The present approach to herbal medicines and fraud with these products do not receive the necessary punishment because it is believed that if the product does not have any therapeutic property, it cannot entail any harm either.
Book Synopsis Competition Law and IP Rights in Pharmaceuticals and Biotechnology by : Björn Lundqvist
Download or read book Competition Law and IP Rights in Pharmaceuticals and Biotechnology written by Björn Lundqvist and published by Oxford University Press, USA. This book was released on 2031-05-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.
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 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 2011-10-25 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 The Business of Healthcare Innovation by : Lawton R. Burns
Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.
Book Synopsis The Oxford Handbook of the Economics of the Biopharmaceutical Industry by : Patricia M. Danzon
Download or read book The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by Oxford University Press. This book was released on 2012-04-12 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.
Book Synopsis A review of UK health research funding by : David Sir Cooksey
Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).
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 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 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.
