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Biotechnology And The Legal Landscape

Author: Pooja Agarwal

Publisher:

Published: 2023-08-18

Total Pages: 0

ISBN-13: 9789358261400

Biotechnology, a rapidly evolving field at the intersection of biology, technology, and innovation, has the potential to revolutionize various sectors, including healthcare, agriculture, and environmental sustainability. As biotechnology continues to advance, it is crucial to understand the legal framework surrounding its research, development, and commercialization. These chapters serves as an introduction to biotechnology and provides an overview of the legal aspects that govern its activities.

The Regulatory Challenge of Biotechnology

Author: Han Somsen

Publisher: Edward Elgar Publishing

Published: 2007-01-01

Total Pages: 291

ISBN-13: 1847204414

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. . . 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 And The Legal Landscape: The Ethical And Regulatory Challenges

Author: Pooja Agarwal

Publisher: Ink of Knowledge

Published:

Total Pages: 93

ISBN-13: 9358261412

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Biotechnology

Author: Michael J. Malinowski

Publisher: Aspen Publishers

Published: 1999

Total Pages: 994

ISBN-13: 9780735503090

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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.

Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology

Author: Thomas H. Murray

Publisher: Wiley-Interscience

Published: 2000-10-10

Total Pages: 580

ISBN-13:

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This set is comprehensive and technically literate and more informative on regulation and policy issues. Thomas Murray is a world-renowned leader in this field.

Biotechnology Law and Policy

Author: Alessandro Stasi

Publisher:

Published: 2023

Total Pages: 0

ISBN-13: 9789819921362

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This book covers an extensive range of issues raised by biotechnological advancements from a regulatory perspective. Written in a clear and readable style, its main objective is to give readers an idea of the relationship between biotechnology and law. Biotechnology advancements and their ethical, moral, economic, and social implications in different fields and the consequential normative demands on the law are crucial to this book. The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety, the current biotechnology regulatory system, and the rules directing the primary agencies that regulate the products of biotechnology, namely the US Food and Drug Administration, the US Department of Agriculture, and the US Environmental Protection Agency, patents and IP rights in biotechnology, the regulation of human genome editing and its impact on health research, law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9, the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and legal issues arising from the use of genetic engineered plants and animals. Presenting arguments that have been drawn from careful examination of various international documents and decisions made by legal institutions and judicial bodies, this book would be a valuable read for practitioners as well as academics of biotechnology law.

The International Law of Biotechnology

Author: Matthias Herdegen

Publisher:

Published: 2023

Total Pages: 0

ISBN-13: 9781035302048

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In this thoroughly updated second edition, Matthias Herdegen provides a comprehensive and contemporary assessment of the regulation of biotechnology processes and products from an international and comparative perspective, complete with analysis of intricate legal and ethical debates. Considering recent advances in biotechnology, this new edition explores how regulatory approaches to controversial issues such as stem cell research, cloning and gene therapy differ across jurisdictions due to conflicting values and risk perceptions. Reflecting on current developments, the book explores the interaction between biotechnology and different fields of law, including: human rights, intellectual property, trade law and environmental law. In doing so, Herdegen investigates complex concerns such as balancing commercial interests with socio-cultural considerations and ensuring respect for human dignity in the pursuit of biomedical research. Furthermore this new edition includes examination of recent developments in areas such as genome editing, biomedicine, COVID-19 vaccines, and patents on essentially biological products, with an entirely revised section on biobanks. Providing a concise and accessible guide to a complex field of international law, this book will be of great value to those researching the law and regulation of biotechnology, biomedicine and biodiversity both within the EU and at an international level. Practicing lawyers will also benefit from a diverse array of sources from a range of legal systems.

Preparing for Future Products of Biotechnology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-07-28

Total Pages: 231

ISBN-13: 0309452058

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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 Growing Gap Between Emerging Technologies and Legal-Ethical Oversight

Author: Gary E. Marchant

Publisher: Springer Science & Business Media

Published: 2011-05-19

Total Pages: 233

ISBN-13: 9400713568

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At the same time that the pace of science and technology has greatly accelerated in recent decades, our legal and ethical oversight mechanisms have become bogged down and slower. This book addresses the growing gap between the pace of science and technology and the lagging responsiveness of legal and ethical oversight society relies on to govern emerging technologies. Whether it be biotechnology, genetic testing, nanotechnology, synthetic biology, computer privacy, autonomous robotics, or any of the other many emerging technologies, new approaches are needed to ensure appropriate and timely regulatory responses. This book documents the problem and offers a toolbox of potential regulatory and governance approaches that might be used to ensure more responsive oversight.

Artificial Intelligence in Healthcare

Author: Adam Bohr

Publisher: Academic Press

Published: 2020-06-21

Total Pages: 385

ISBN-13: 0128184396

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Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. Highlights different data techniques in healthcare data analysis, including machine learning and data mining Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks Includes applications and case studies across all areas of AI in healthcare data