Biotechnology Legislation And Regulation

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The Regulatory Challenge of Biotechnology

Author : Han Somsen
Publisher : Edward Elgar Publishing
Page : 291 pages
File Size : 54,9 Mb
Release : 2007-01-01
Category : Science
ISBN : 9781847204417

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The Regulatory Challenge of Biotechnology by Han Somsen Pdf

. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and development studies. It is a storehouse of learning and practical knowledge for anyone interested in environmental policy, biosafety issues, biotechnology processes and associated regulatory constraints. Marcelin Tonye Mahop, Review of European Community and International Environmental Law For bioethicists, legal scholars and regulators struggling with what controls to place on biotechnology, this is required reading. John Avellanet, Journal of Commercial Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property. With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.

Biotechnology, Legislation and Regulation

Author : Anonim
Publisher : Unknown
Page : 64 pages
File Size : 44,5 Mb
Release : 1996
Category : Agricultural biotechnology
ISBN : MINN:31951D01299944M

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Biotechnology, Legislation and Regulation by Anonim Pdf

Biotechnology and the Law

Author : Hugh B. Wellons
Publisher : American Bar Association
Page : 1016 pages
File Size : 45,9 Mb
Release : 2007
Category : Biotechnology
ISBN : 1590317610

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Biotechnology and the Law by Hugh B. Wellons Pdf

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.

The Regulation of Genetically Modified Organisms

Author : Luc Bodiguel,Michael Cardwell
Publisher : Unknown
Page : 448 pages
File Size : 49,9 Mb
Release : 2010
Category : Business & Economics
ISBN : 9780199542482

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The Regulation of Genetically Modified Organisms by Luc Bodiguel,Michael Cardwell Pdf

The regulation of genetically modified organisms (GMOs) continues to generate controversy. On the one hand, they are actively promoted by the biotechnology industry as vital to ensuring food security. Yet, on the other hand, consumer resistance persists, not least in the European Union, and such lack of confidence extends not just to GM food itself but also to the regulatory regime, where legal issues are inextricably linked with economics and politics. This edited collection provides a novel contribution to the ongoing debate, recognizing that the legislative environment is complicated by forces as varied as national public opinion and world trade commitments. The book is divided into four parts. The first of these addresses the influence in this context of both civil society and economic imperatives. The second part is directed more specifically to the measures that have been implemented in the European Union, considering multi-level governance, wider aspects of food law, co-existence with conventional and organic crops, and environmental liability. The third part is comparative in focus, with chapters covering the diverse regimes implemented in Africa, Australia, North America and South America. The book concludes with chapters on world trade and international considerations, including analysis of the Biotech case.

Biotechnology: Legislation and Regulation

Author : Scott A. Leonard,Raymond Dobert
Publisher : DIANE Publishing
Page : 61 pages
File Size : 45,5 Mb
Release : 1997-02
Category : Electronic
ISBN : 9780788138690

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Biotechnology: Legislation and Regulation by Scott A. Leonard,Raymond Dobert Pdf

Bibliography of 323 citations in English.

Biotechnology

Author : Michael J. Malinowski,Beth E. Arnold
Publisher : Aspen Publishers
Page : 994 pages
File Size : 46,5 Mb
Release : 1999
Category : Law
ISBN : 0735503095

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Biotechnology by Michael J. Malinowski,Beth E. Arnold Pdf

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.

Preparing for Future Products of Biotechnology

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
Publisher : National Academies Press
Page : 231 pages
File Size : 54,6 Mb
Release : 2017-07-28
Category : Science
ISBN : 9780309452052

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Preparing for Future Products of Biotechnology by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System Pdf

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.

The Regulation of Agricultural Biotechnology

Author : Robert E. Evenson,V. Santaniello
Publisher : CABI
Page : 328 pages
File Size : 49,5 Mb
Release : 2004-03-29
Category : Agricultural biotechnology
ISBN : 0851999700

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The Regulation of Agricultural Biotechnology by Robert E. Evenson,V. Santaniello Pdf

The regulatory systems in place prior to the development and expansion of agricultural biotechnology are still responding to this new form of technology. Such systems include trade law, intellectual property law, contract law, environmental regulations and biosafety regulations.This book reviews these regulatory changes and consists of 24 chapters developed from papers presented at a conference of the International Consortium on Agricultural Biotechnology Research, held in Italy in July 2002. It primarily considers the relationship between these changes and innovation, market development and international trade.

Regulation of Agricultural Biotechnology: The United States and Canada

Author : Chris A. Wozniak,Alan McHughen
Publisher : Springer Science & Business Media
Page : 399 pages
File Size : 40,6 Mb
Release : 2012-10-05
Category : Science
ISBN : 9789400721562

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Regulation of Agricultural Biotechnology: The United States and Canada by Chris A. Wozniak,Alan McHughen Pdf

Agricultural biotechnology takes many forms and applications, with the number and diversity of products ever increasing. With this rapid development, regulatory authorities have sought to keep pace through regulatory adjustments and advances to ensure the safe and beneficial use of this critical technology. The regulatory systems for the U.S. and Canada are not static and must evolve in order to maintain relevance, efficiency and applicability to the challenges encountered. The diverse authors, drawn from the biotechnology industry, academia, government research and regulatory agencies, offer their perspectives of the historical and current system and suggest where it can be improved in the future. Based upon vast experience interacting with the regulatory system, the editors and authors offer demystifying views of the US and Canadian regulatory structures and how they came to be. We know of no other effort to present the biotechnology regulatory systems of the US and Canada in an open forum which will benefit those in the regulated community as well as those charged with oversight of the products of biotechnology, and ultimately the consumer!

Biotechnology Regulation and GMOs

Author : Naveen Thayyil
Publisher : Edward Elgar Publishing
Page : 285 pages
File Size : 53,8 Mb
Release : 2014-03-28
Category : Law
ISBN : 9781783473885

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Biotechnology Regulation and GMOs by Naveen Thayyil Pdf

This thoughtful book explores how EU law treats serious disagreements about the development and use of a radically new technology like genetic modification. Relevant EU laws are examined to analyse the room available, or possible, for public participat

The International Law of Biotechnology

Author : Matthias Herdegen
Publisher : Edward Elgar Publishing
Page : 208 pages
File Size : 44,9 Mb
Release : 2024-06-30
Category : Biotechnology
ISBN : 9781786435965

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The International Law of Biotechnology by Matthias Herdegen Pdf

Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.

Biotechnology, Legislation and Regulation

Author : Kim Guenther
Publisher : Unknown
Page : 60 pages
File Size : 42,6 Mb
Release : 1994
Category : Agricultural biotechnology
ISBN : MINN:31951D011298435

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Biotechnology, Legislation and Regulation by Kim Guenther Pdf

Biosafety Regulations in Developing Countries

Author : E. J. Trigo
Publisher : IICA Biblioteca Venezuela
Page : 26 pages
File Size : 55,5 Mb
Release : 1990
Category : Biotechnology
ISBN : 8210379456XXX

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Biosafety Regulations in Developing Countries by E. J. Trigo Pdf

Animal Biotechnology

Author : National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Board on Agriculture and Natural Resources,Committee on Agricultural Biotechnology, Health, and the Environment,Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology
Publisher : National Academies Press
Page : 201 pages
File Size : 54,9 Mb
Release : 2002-12-29
Category : Technology & Engineering
ISBN : 9780309084390

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Animal Biotechnology by National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Board on Agriculture and Natural Resources,Committee on Agricultural Biotechnology, Health, and the Environment,Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology Pdf

Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.