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Legal Regulation Of The British Pharmaceutical Market
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Author :Great Britain: Parliament: House of Commons: Health Committee Publisher :The Stationery Office ISBN 13 :9780215024572 Total Pages :556 pages Book Rating :4.0/5 (245 download)
Book Synopsis The Influence of the Pharmaceutical Industry by : Great Britain: Parliament: House of Commons: Health Committee
Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.
Book Synopsis Competition and Patent Law in the Pharmaceutical Sector by : Giovanni Pitruzzella
Download or read book Competition and Patent Law in the Pharmaceutical Sector written by Giovanni Pitruzzella and published by Kluwer Law International. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Book Synopsis Advances in Pharma Business Management and Research by : Lars Schweizer
Download or read book Advances in Pharma Business Management and Research written by Lars Schweizer and published by Saint Philip Street Press. This book was released on 2020-10-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master's theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Book Synopsis Dale and Appelbe's Pharmacy and Medicines Law by : Gordon E. Appelbe
Download or read book Dale and Appelbe's Pharmacy and Medicines Law written by Gordon E. Appelbe and published by Pharmaceutical Press. This book was released on 2013 with total page 609 pages. Available in PDF, EPUB and Kindle. Book excerpt: This tenth edition of Dale and Appelbe's Pharmacy and Medicines Law, previously Dale and Appelbe's Pharmacy Law and Ethics, is your definitive guide to law relating to pharmacy and medicine practice in Great Britain. It covers law and professional regulation that all pharmacy and medicine professionals need to know.
Book Synopsis Guide to EU and UK Pharmaceutical Regulatory Law by : Sally Shorthose
Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Book Synopsis Pharmaceutical Medicine by : Adrian Kilcoyne
Download or read book Pharmaceutical Medicine written by Adrian Kilcoyne and published by OUP Oxford. This book was released on 2013-05-23 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
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 Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Download or read book Big Pharma written by Jacky Law and published by Robinson. This book was released on 2006 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical medicine is very, very big business. The top ten players earned more than $200 billion in 2003. One drug, Pfizer's cholesterol pill Lipitor, had sales of more than $9 billion. This kind of money buys an awful lot of friends among doctors and politicians. Most of those involved in the formulation of public health policy seems happy with the present system. The trouble is that the public is starting to have doubts. There is a growing sense that the vast profits of drug companies and their control of the research agenda might not be that good for our health. Jacky Law takes the reader on a journey through the pharmaceutical business and shows how the public is quite right to be concerned about conventional medicine, as it has developed since the late 1970s. She tells a story of spectacular regulatory failure, phenomenally high prices, betrayal of the public interest and a growing awareness among ordinary people that things could be very different. Sophisticated marketing and public relations, not scientific excellence, have helped corporations to preside unchallenged over matters of life and death. It is time, Law argues, for us to take responsibility for our health, not as passive consumers of pharmaceutical medicine, but as informed citizens.
Book Synopsis Pharmacy and Medicines Law in Ireland by : Peter B. Weedle
Download or read book Pharmacy and Medicines Law in Ireland written by Peter B. Weedle and published by Pharmaceutical Press. This book was released on 2011 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: -sources of Irish law. --
Book Synopsis Pharmaceuticals, Corporate Crime and Public Health by : Graham Dukes
Download or read book Pharmaceuticals, Corporate Crime and Public Health written by Graham Dukes and published by Edward Elgar Publishing. This book was released on 2014-06-27 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Book Synopsis Intellectual Property and Public Health in the Developing World by : Monirul Azam
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.
Book Synopsis Ways of Regulating Drugs in the 19th and 20th Centuries by : Jean-Paul Gaudillière
Download or read book Ways of Regulating Drugs in the 19th and 20th Centuries written by Jean-Paul Gaudillière and published by Springer. This book was released on 2012-12-03 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection takes the perspective that the historiography of science, technology, and medicine needs a broader approach toward regulation. The authors explore the distinct social worlds involved in regulation, the forms of evidence and expertise mobilized, and means of intervention chosen to tame drugs in factories, consulting rooms and courts.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309468086 Total Pages :235 pages Book Rating :4.3/5 (94 download)
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Book Synopsis Navigating European Pharmaceutical Law by : Maria Isabel Manley
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
Book Synopsis Pharmaceutical Medicine and Translational Clinical Research by : Divya Vohora
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
