The Regulatory Challenge Of Biotechnology

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The Regulatory Challenge Of Biotechnology

Author : Han Somsen
ISBN : 9781847204417
Genre : Science
File Size : 75.49 MB
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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.
Category: Science

The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals

Author : John Geigert
ISBN : 9783030137540
Genre : Medical
File Size : 57.88 MB
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Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Category: Medical

Biotechnology Regulation And Gmos

Author : Naveen Thayyil
ISBN : 9781783473885
Genre : Law
File Size : 60.93 MB
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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
Category: Law

Biotechnology Regulation And Trade

Author : Stuart J. Smyth
ISBN : 9783319532950
Genre : Political Science
File Size : 24.31 MB
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This book discusses the regulatory and trade challenges facing the global adoption of biotechnological products and offers strategies for overcoming these obstacles and moving towards greater global food security. The first section of the book establishes the context of the conflict, discussing the challenges of global governance, international trade, and the history of regulation of genetically modified (GM) crops. In this section, the authors emphasize the shift from exclusively science-based regulation to the more socio-economically focused framework established by the Cartagena Protocol on Biosafety, which was adopted in 2000. The second section of the book provides a snapshot of the current state of international GM crop adoption and regulation, highlighting the US, Canada, and the EU. The final section of the book identifies options for breaking the gridlock of regulation and trade that presently exist. This book adds to the current literature by providing new information about innovative agricultural technologies and encouraging debate by providing an alternative to the narratives espoused by environmental non-governmental organizations. This book will appeal to students of economics, political science, and policy analysis, as well as members of regulatory agencies and agricultural industry firms.
Category: Political Science

Regulating Next Generation Agri Food Biotechnologies

Author : Michael Howlett
ISBN : 9781136338441
Genre : Science
File Size : 34.85 MB
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Agri-food bio-technology policy and regulation is transitioning from an early period focused on genetic engineering technologies to ‘next-generation’ rules and regulatory processes linked to challenges originating in a wide variety of new technological processes and applications. Can lessons learned from past and current regulatory oversights of agricultural biotechnology – and other high-technology sectors – help us address new and emerging regulatory challenges in the agri-food genetics sector? The expert contributors in this volume discuss the experiences of a wide range of North American, European and Asian countries with high technology regulation to address four key questions related to the past and future development of agri-food genomics regulation across the globe. how unique is agri-food biotechology regulation, and how can it be evaluated using the existing tools of regulatory analysis developed in examinations of other sectors? is a ‘government to governance’ model of regulatory regime development found in many other sectors relevant in this rapidly evolving sphere of activity? is a stages model of regulatory regime development accurate? And, if so, at which stage are we currently positioned in the regulation of agri-food genomics products and technologies? what drives movement between stages in different countries and sectors? In assessing such drivers, what are the key links between sectoral (meso) developments and more general macro and micro developments such as international relations and administrative behaviour? By updating, extending and challenging earlier empirical and theoretical social science perspectives on agricultural bio-technological regulation, this volume helps to inform future policy formulation. It will be of interest to practitioners and students of biotechnology, agriculture, and science and technology policy, and regulatory processes more generally.
Category: Science

Ocean Challenge

Author :
ISBN : UCSD:31822032641797
Genre : Oceanography
File Size : 89.43 MB
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Category: Oceanography

The Global Challenge Of Marine Biotechnology

Author : Raymond A. Zilinskas
ISBN : UCSD:31822023035793
Genre : Nature
File Size : 29.7 MB
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In 1966 Congress passed the National Sea Grant College Program Act to promote marine research, education, and extension services in institutions along the nation's ocean and Great Lakes coasts. In Maryland a Sea Grant Program -- a partnership among federal and state governments, universities, and industries -- began in 1977, and in 1982 the University of Maryland was named the nation's seventeenth Sea Grant College.The Maryland Sea Grant College focuses its efforts on the Chesapeake Bay, with emphasis on the marine concerns of fisheries, seafood technology, and environmental quality.This report addresses the emerging science and developing technologies encompassed by marine biotechnology. It contains a broad overview of marine biotechnology, sets forth industrial realities, and assesses the future potential of this new field of biotechnology.The report has eight chapters. The first contains a wide range of major scientific achievements in marine biotechnology. The subjects encompassed within marine biotechnology are grouped within six areas: aquaculture, marine animal health, marine natural health, marine natural products, biofilm and bioadhesion in the marine environment, bioremediation, and marine ecology and biological oceanography. The remaining chapters detail an extensive survey and status report on marine biotechnology in the United States, Japan, Australia, and Norway.
Category: Nature

Newsletter

Author : Agricultural Research and Extension Network
ISBN : CORNELL:31924094724345
Genre : Agricultural development projects
File Size : 82.70 MB
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Category: Agricultural development projects

Biotechnology Progress

Author :
ISBN : UOM:39076000718416
Genre : Bioengineering
File Size : 61.4 MB
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Category: Bioengineering

Agricultural Biotechnology And Transatlantic Trade

Author : Grant Isaac
ISBN : 0851997007
Genre : Science
File Size : 60.54 MB
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Genetically modified (GM) agricultural crops which are approved as safe in North America (Canada and the United States) are facing significant regulatory hurdles in gaining access to the European Union. The development and commercialization of GM crops illustrate a complex challenge facing trade diplomacy - the challenge of regulatory regionalism created by social regulatory barriers.
Category: Science

Annual Report

Author : Canadian Biotechnology Advisory Committee
ISBN : UIUC:30112063296799
Genre : Biotechnology
File Size : 33.22 MB
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Category: Biotechnology

Agricultural Biotechnology

Author : Allan Eaglesham
ISBN : WISC:89086130275
Genre : Agricultural biotechnology
File Size : 43.55 MB
Format : PDF
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Category: Agricultural biotechnology

Journal Of World Trade

Author :
ISBN : STANFORD:36105063854801
Genre : Commerce
File Size : 73.70 MB
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Category: Commerce