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Biotechnology Law Business And Regulation
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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 Building Biotechnology by : Yali Friedman
Download or read book Building Biotechnology written by Yali Friedman and published by . This book was released on 2014 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309452058 Total Pages :231 pages Book Rating :4.3/5 (94 download)
Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Book Synopsis Biotechnology, Bioethics and the Law by : Michele Goodwin
Download or read book Biotechnology, Bioethics and the Law written by Michele Goodwin and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: With every new advancement in biotechnology, ethical and legal questions arise. Sometimes, those questions are easily addressed and settled. However, more often, these issues are not easily resolved and at times are left to the democratic process or markets to establish the boundaries of technological pioneering. In Biotechnology, Bioethics, and the Law, the authors canvass the broader fields, valleys, and pastures of biotechnology, providing mostly cases, but at times law review and medical journal articles to provide a comprehensive look at a given technology. Their goal is to encourage a critical engagement on the topics shared in the book, whether on cloning animals and plants for human consumption, drug regulation, or human reproduction and eugenics. Many of the cases contained in the book provide novel questions for judges. Some of these cases are the first impression for the courts, meaning that judges are attempting to learn the law in these new areas and develop its jurisprudence at the same time that the public -- or the reader -- are doing the same. As students read the cases, they are asked to consider whether they would reach the same conclusions as the courts. Are these issues better left to legislatures? Are markets the best forum for efficiently resolving biotechnological conundrums?
Book Synopsis Regulation of Genome Editing in Plant Biotechnology by : Hans-Georg Dederer
Download or read book Regulation of Genome Editing in Plant Biotechnology written by Hans-Georg Dederer and published by Springer. This book was released on 2019-08-16 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.
Book Synopsis Biotechnology by : Michael J. Malinowski
Download or read book Biotechnology written by Michael J. Malinowski and published by Aspen Publishers. This book was released on 1999 with total page 994 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology: Law, Business, and Regulation offers comprehensive analysis on the advancement of a biotech discovery into a commercial product, making it easy for you to identify legal issues as they arise in the R & D and commercialization process; anticipate forthcoming legal and regulatory challenges; and develop an effective strategy for efficient commercialization. Real product and industry examples are used throughout the handbook and pending legislation is discussed and analyzed. This is the first book to pull together all the legal issues associated with the burgeoning biotechnology industry. The author explains and analyzes the current dimensions of biotechnology law, with in-depth attention to: the markets for biotech products -- patent protection -- confidentiality and other intellectual property issues -- government-supported cooperative R & D agreements -- corporate securities issues -- clinical trial agreements, including informed consent, liability, and insurance issues -- FDA regulation and tracks to speed product approval and commercialization -- legal implications of foreign R & D -- public health and policy considerations -- legislation prohibiting discrimination on the basis of genetic information -- and ethical norms of the scientific and medical communities.
Book Synopsis Law Relating to Biotechnology by : N. S. Sreenivasulu
Download or read book Law Relating to Biotechnology written by N. S. Sreenivasulu and published by Oxford University Press, USA. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology: The Science of Wonders --Biotechnology Dynamics and Applications --Evolving a Policy Framework for Biotechnology --Intellectual Property Rights in Biotechnology --Biotechnology, Trade, and Environment --Human Rights Concerns in Biotechnology --Biotechnology Regulation in India.
Book Synopsis Regulation of Synthetic Biology by : Alison McLennan
Download or read book Regulation of Synthetic Biology written by Alison McLennan and published by Edward Elgar Publishing. This book was released on 2018-04-27 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
Book Synopsis Biotechnology and Software Patent Law by : Arezzo, E. Ghidini, G.
Download or read book Biotechnology and Software Patent Law written by Arezzo, E. Ghidini, G. and published by Edward Elgar Publishing. This book was released on 2011 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'The art of editing is to bring contributions together, which melt into one book. This is what Emanuela Arezzo and Gustavo Ghidini have achieved with their own critical mind by composing a book of papers, in which internationally renowned experts measure the tensions created for the patent system by the needs and problems of protecting biotechnological and software inventions. All together, they present a comparative law challenge to the very fundaments of patent protection. As such, they are or may become a "must read".' Hanns Ullrich, College of Europe, Bruges, Belgium 'Arezzo and Ghidini have put together a fine collection of essays addressing developments in patent law from general themes to emerging ones in the infotech and biotech sectors. It is notable that the international array of authors includes contributions from both established and rising young scholars, all of them ably tackling difficult issues that merit our attention.' Rudolph J.R. Peritz, New York Law School, US The new millennium has carried several challenges for patent law. This up-to-date book provides readers with an important overview of the most critical issues patent law is still facing today at the beginning of the twenty first century, on both sides of the Atlantic. New technological sectors have emerged, each one with its own features with regard to innovation process and pace. From the most controversial cases in biotech to the most recent decisions in the field of software and business methods patent, patent law has tried to stretch its boundaries in a way to accommodate such new and controversial subject matters into its realm. Biotechnology and Software Patent Law will strongly appeal to postgraduate students specializing in IP law, international law, commercial and business law, competition law as well as IP scholars, academics and lawyers.
Book Synopsis Global Business Regulation by : John Braithwaite
Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Book Synopsis Intellectual Property and Biotechnology by : Matthew Rimmer
Download or read book Intellectual Property and Biotechnology written by Matthew Rimmer and published by Edward Elgar Publishing. This book was released on 2008-01-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.
Book Synopsis EU Regulation of GMOs by : Maria Lee
Download or read book EU Regulation of GMOs written by Maria Lee and published by Edward Elgar Publishing. This book was released on 2009-01-01 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lee s book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation. Tracey Epps, European Review of Agricultural Economics Maria Lee s work is a successful attempt to illustrate the big legal issues behind the regulation of genetically modified organisms (GMOs). This study, which is thorough and well documented, is particularly welcomed in view of the need for a dialogue between different legal specialisms for which GMOs are a relevant area of research. . . [The] book provides a very interesting and insightful examination of the legal problems raised by GMOs. I would warmly recommend its reading to academics and practitioners who are interested in European risk regulation law, environmental law, biotechnology and trade law. Sara Poli, European Law Review Genetically modified organisms (GMOs) are an extraordinary innovation. They raise great expectations of economic prosperity and improved capacity to address pressing problems of poverty and environmental degradation, whilst simultaneously raising great concerns about the type of social and physical world they promise. Finding space in regulation to consider the full range of issues provoked by GMOs is a huge challenge. This book explores the EU s elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts. This book will be of interest to academics and students in both law and social sciences, as well as practising lawyers and policy makers. It addresses questions that are significant for those involved in environmental or food issues, as well as specialists in GMOs.
Book Synopsis A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition by : Stephen M. Kanovsky
Download or read book A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Book Synopsis Economic Regulation and Its Reform by : Nancy L. Rose
Download or read book Economic Regulation and Its Reform written by Nancy L. Rose and published by University of Chicago Press. This book was released on 2014-08-29 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.
Book Synopsis Medical Devices Law and Regulation Answer Book by : Suzan Onel
Download or read book Medical Devices Law and Regulation Answer Book written by Suzan Onel and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Oxford Handbook of Law, Regulation and Technology by : Roger Brownsword
Download or read book The Oxford Handbook of Law, Regulation and Technology written by Roger Brownsword and published by Oxford University Press. This book was released on 2017-07-24 with total page 1342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The variety, pace, and power of technological innovations that have emerged in the 21st Century have been breathtaking. These technological developments, which include advances in networked information and communications, biotechnology, neurotechnology, nanotechnology, robotics, and environmental engineering technology, have raised a number of vital and complex questions. Although these technologies have the potential to generate positive transformation and help address 'grand societal challenges', the novelty associated with technological innovation has also been accompanied by anxieties about their risks and destabilizing effects. Is there a potential harm to human health or the environment? What are the ethical implications? Do this innovations erode of antagonize values such as human dignity, privacy, democracy, or other norms underpinning existing bodies of law and regulation? These technological developments have therefore spawned a nascent but growing body of 'law and technology' scholarship, broadly concerned with exploring the legal, social and ethical dimensions of technological innovation. This handbook collates the many and varied strands of this scholarship, focusing broadly across a range of new and emerging technology and a vast array of social and policy sectors, through which leading scholars in the field interrogate the interfaces between law, emerging technology, and regulation. Structured in five parts, the handbook (I) establishes the collection of essays within existing scholarship concerned with law and technology as well as regulatory governance; (II) explores the relationship between technology development by focusing on core concepts and values which technological developments implicate; (III) studies the challenges for law in responding to the emergence of new technologies, examining how legal norms, doctrine and institutions have been shaped, challenged and destabilized by technology, and even how technologies have been shaped by legal regimes; (IV) provides a critical exploration of the implications of technological innovation, examining the ways in which technological innovation has generated challenges for regulators in the governance of technological development, and the implications of employing new technologies as an instrument of regulatory governance; (V) explores various interfaces between law, regulatory governance, and new technologies across a range of key social domains.
Book Synopsis Biotechnology, Legislation and Regulation by : Robert D. Warmbrodt
Download or read book Biotechnology, Legislation and Regulation written by Robert D. Warmbrodt and published by . This book was released on 1991 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
