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Author : Adrian Zahl
Publisher :
ISBN 13 : 9780820557823
Total Pages : 0 pages
Book Rating : 4.5/5 (578 download)
Download or read book International Pharmaceutical Law and Practice written by Adrian Zahl and published by . This book was released on 2004 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Adrian Zahl
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (833 download)
Download or read book International Pharmaceutical Law and Practice written by Adrian Zahl and published by . This book was released on 2006 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Howard L. Dorfman
Publisher :
ISBN 13 : 9781402438486
Total Pages : pages
Book Rating : 4.4/5 (384 download)
Download or read book Pharmaceutical Compliance and Enforcement Answer Book written by Howard L. Dorfman and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Pablo Figueroa
Publisher : Edward Elgar Publishing
ISBN 13 : 1785362615
Total Pages : 758 pages
Book Rating : 4.7/5 (853 download)
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Author : M.N.G. Dukes
Publisher : Elsevier
ISBN 13 : 0080459366
Total Pages : 429 pages
Book Rating : 4.0/5 (84 download)
Download or read book The Law and Ethics of the Pharmaceutical Industry written by M.N.G. Dukes and published by Elsevier. This book was released on 2005-11-04 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.*Provides a balanced picture of the current role of the pharmaceutical industry in society*Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases*This is the only book addressing the legal implications of big pharma activities and ethical standards
Author : Monirul Azam
Publisher : Open Book Publishers
ISBN 13 : 1783742313
Total Pages : 193 pages
Book Rating : 4.7/5 (837 download)
Download or read book Intellectual Property and Public Health in the Developing World written by Monirul Azam and published by Open Book Publishers. This book was released on 2016-05-30 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Across the world, developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book, Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil, China, India, and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azam's legal expertise, concern for public welfare, and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organization's TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents, the consequences for developing countries, and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh, offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must-read for public policy-makers, academics and students, non-governmental organizations, and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people.
Author : Richard N. Spivey
Publisher : Psychology Press
ISBN 13 : 9780866569064
Total Pages : 686 pages
Book Rating : 4.5/5 (69 download)
Download or read book International Pharmaceutical Services written by Richard N. Spivey and published by Psychology Press. This book was released on 1992 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comparative overview of the laws which govern pharmacy services in different countries, the organization of the medical community and health care delivery services, and the involvement of pharmacy practice within the health care delivery system. Annotation copyright Book News, Inc. Portland, Or.
Author : Lionel D. Edwards
Publisher : John Wiley & Sons
ISBN 13 : 9780470093146
Total Pages : 780 pages
Book Rating : 4.0/5 (931 download)
Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS
Author : Srividhya Ragavan
Publisher : Routledge
ISBN 13 : 1000398706
Total Pages : 522 pages
Book Rating : 4.0/5 (3 download)
Download or read book Intellectual Property Law and Access to Medicines written by Srividhya Ragavan and published by Routledge. This book was released on 2021-07-28 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.
Author : Maria Isabel Manley
Publisher : Oxford University Press, USA
ISBN 13 : 9780198717997
Total Pages : 0 pages
Book Rating : 4.7/5 (179 download)
Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by Oxford University Press, USA. This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases for application / Maria Isbel Manley and Libby Amos -- Pricing, reimbursement, and health technology appraisals (market access) / Maria Isabel Manley and Maria Georgiou -- Paediatrics / Georgia Gavriilidou -- Orphan drugs / Maria Isabel Manley and Chris Boyle -- Biological medicinal products and biosimilars / Dev Kumar and Lauren Wilks -- Regulatory data protection / Maria Isabel Manley and Grant Strachan -- Supplementary protection certificates / Maria Isabel Manley and Marina Vickers -- Maximisation of regulatory IP rights / Maria Isabel Manley and Marina Vickers -- The interaction between intellectual property law and competition law / Pat Treacy -- Access to information / Vincenzo Salvatore -- Litigating decisions of regulatory authorities / Kelyn Bacon, QC and Hugo Leith -- Pharmacovigilance / Maria Isabel Manley abd Edward Bray -- Data protection / Hazel Grant -- The promotion of medicinal products in the EU / Maria Isabel Manley and Libby Amos -- Borderline products / Maria Isabel Manley and Joanna Hook -- Product liability : the UK perspective / Mark Brown -- Pharmaceutical licensing and collaboration agreements : key consideration from the licensee's perspective / Jerry Temko -- Trade mark protection and enforcement in the pharmaceutical field / Sally Dunstan
Author : Joseph M. Gabriel
Publisher : University of Chicago Press
ISBN 13 : 022610821X
Total Pages : 345 pages
Book Rating : 4.2/5 (261 download)
Download or read book Medical Monopoly written by Joseph M. Gabriel and published by University of Chicago Press. This book was released on 2014-10-24 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: During most of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.
Author : Frederick M. Abbott
Publisher : Edward Elgar Publishing
ISBN 13 : 1849801843
Total Pages : 319 pages
Book Rating : 4.8/5 (498 download)
Download or read book Global Pharmaceutical Policy written by Frederick M. Abbott and published by Edward Elgar Publishing. This book was released on 2009-01-01 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a strong argument that people throughout the world have a right to receive the medicines they need in an appropriate, affordable, and timely way. Global Pharmaceutical Policy describes the laws, policies, and customs relating to the development and provision of medicines, identifies their strengths and weakness, and then proposes global solutions for getting things better. Here is a masterpiece written in a clear and elegant style. Together, Dukes and Abbott have experience and insight that are unrivalled. Joe Collier, Emeritus Professor of Medicines Policy, St George s, University of London, UK Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world s poor see little effort to address diseases prevalent in less affluent societies, while the world s wealthy are overusing prescription drugs, risking their health and wasting resources. As the global economic crisis exacerbates pressure on health care budgets, a new presidential administration in Washington, DC has committed to broad health care reform. These circumstances form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.
Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
ISBN 13 : 1509943005
Total Pages : 417 pages
Book Rating : 4.5/5 (99 download)
Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Bryan Mercurio
Publisher : Taylor & Francis
ISBN 13 : 1317389794
Total Pages : 258 pages
Book Rating : 4.3/5 (173 download)
Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by Taylor & Francis. This book was released on 2017-02-17 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges
Author : Philip W. Grubb
Publisher : Oxford University Press, USA
ISBN 13 :
Total Pages : 552 pages
Book Rating : 4.3/5 (91 download)
Download or read book Patents for Chemicals, Pharmaceuticals and Biotechnology written by Philip W. Grubb and published by Oxford University Press, USA. This book was released on 2004 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Previous editions, 1st and 2nd, published under titles : 1st (1982) Patents for chemists ; 2nd (1986) Patents in chemistry and biotechnology ; 3rd edition published in 1999.
Author : Bryan Mercurio
Publisher :
ISBN 13 : 1316512347
Total Pages : 241 pages
Book Rating : 4.3/5 (165 download)
Download or read book Drugs, Patents and Policy written by Bryan Mercurio and published by . This book was released on 2018-06-28 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive review of Hong Kong's pharmaceutical patent law that will influence debate and inform public policy.
Author : Akira Negishi
Publisher : Springer Nature
ISBN 13 : 9811678146
Total Pages : 252 pages
Book Rating : 4.8/5 (116 download)
Download or read book Competition Law and Policy in the Japanese Pharmaceutical Sector written by Akira Negishi and published by Springer Nature. This book was released on 2022-02-08 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com
