Download or read book Health Canada s Role in the Regulation of Products from Biotechnology written by and published by . This book was released on 2008 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Genetically Engineered Crops written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-01-28 with total page 607 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation. Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.
Download or read book Regulation of Agricultural Biotechnology The United States and Canada written by Chris A. Wozniak and published by Springer Science & Business Media. This book was released on 2012-08-29 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a practical, didactic format designed to deliver point-of-care information to practitioners of cardiology as well as assist non-cardiologists with the efficient management of cardiac disease, this highly illustrated manual is an essential reference.
Download or read book Health and Sustainability in the Canadian Food System written by Rod MacRae and published by UBC Press. This book was released on 2012-07-18 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Civil society organizations are among the most vociferous critics of the modern food system. Yet even after decades of campaigns, governments have failed to address health and sustainability issues in a systematic way. New approaches are in order, and this volume showcases the research of experts from various disciplines who argue that solutions lie not just in lobbying elected officials but rather in initiatives at the subparliamentary level. Case studies on a range of topics, from breastfeeding and sustainable pest management promotion to programs such as Canada’s Action Plan on Food Security, tell a story of misguided campaigns and missed opportunities. Real change, this inspiring volume suggests, is possible. It will come when advocacy groups develop innovative strategies of influencing decision makers more resistant to public pressure: business lobbies well connected to government agencies, middle managers, and ministries unused to collaborating across departmental mandates.
Download or read book Biotechnology Regulation in Canada written by Canada. Parliament. House of Commons. Standing Committee on Environment and Sustainable Development and published by . This book was released on 1996 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer. This book was released on 2015-09-15 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Download or read book Socio Economic Considerations in Biotechnology Regulation written by Karinne Ludlow and published by Springer Science & Business Media. This book was released on 2013-12-03 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within the context of the Convention on Biological Diversity (CBD), the Cartagena Protocol on Biosafety (CPB) was established as an implementing agreement. The CPB is an international agreement establishing the rights of recipient countries to be notified of and to approve or reject the domestic import and/or production of living modified organisms (LMOs). Decisions regarding import/production are to be on the basis of a biosafety assessment. Article 26.1 of the CPB allows for the (optional) inclusion of socio-economic considerations (SECs) into that biosafety assessment process. This book compiles expert assessments of the issues relevant to SEC assessment of LMOs and fundamental for decisions regarding whether to undertake such assessments at all. It includes an overview of the inclusion of SEC assessment in the regulation of LMOs that looks at the rationale for the inclusion of SECs, in the context of the existing science-based risk assessment systems. This book reviews the various factors that can and have been suggested for inclusion in SEC assessment, and provides a meaningful dialogue about the contrasts, benefits and tradeoffs that are, and will, be created by the potential move to the inclusion of SECs in the regulation of LMOs, making it of interest to both academics and policy-makers.
Download or read book The Intellectual Property Regulatory Complex written by Emily Marden and published by UBC Press. This book was released on 2016-03-06 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in agricultural genomics could help address pressing global issues, such as world hunger, by improving crop yield. However, overlap and conflict in intellectual property and biosafety regimes – known collectively as the “Intellectual Property–Regulatory Complex” – create significant barriers to innovation. In this collection, leading legal, policy, and economics experts analyze the impact of the Complex on agricultural genomics. They reveal how it impacts scientific advancement in ways that are underappreciated when intellectual property and biosafety regimes are examined in isolation. After identifying how the interplay between multiple regimes impedes research, development, and product distribution, they propose solutions that would further the aims of the current intellectual property and biosafety regimes while enabling growth and innovation in agricultural genomics.
Download or read book Applications of Gene Based Technologies for Improving Animal Production and Health in Developing Countries written by Harinder P.S. Makkar and published by Springer Science & Business Media. This book was released on 2005-08-12 with total page 787 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern Biotechnology has potential for solving many problems associated with animal productivity and health and offers exciting opportunities for enhancing agricultural productivity. At present the focus is, however, on the issues and problems of significance for livestock producers in the developed world. In order to fully realize the benefits of this technology in developing countries, there is a need to identify, characterize and apply appropriate gene-based technologies for these regions. These proceedings present peer reviewed state-of-the-art papers describing the achievements in the areas of animal breeding and genetics, animal nutrition, animal health, and environment, ethics, safety, and regulatory aspects of gene-based technologies; achievements which could be realized using these modern scientific tools to maximise the benefits from the 'livestock revolution' that is taking place; and the constraints in the use of gene-based technologies and their specific research needs. This book will help in bridging the wide gap between developed and developing countries, in the development and use of gene-based technologies, and to elucidate the current and future roles of such technologies in the developing world. It is a good reference source for researchers, students and policy-makers alike.
Download or read book Strategic Science in the Public Interest written by G. Bruce Doern and published by University of Toronto Press. This book was released on 2007-01-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past twenty years have seen considerable shifts and struggles in government science that is, in the way the state funds, supports, regulates, conducts and uses scientific and technological activity. Focusing on federal labs and agencies, Strategic Science in the Public Interest explores how these labs have been located within, and often buried by, the larger commercially-focussed federal innovation agenda. G. Bruce Doern and Jeffrey S. Kinder examine four labs whose mandates deal with the Alberta oil sands, environmental technologies, wildlife research, and mining and metals, respectively. The authors use these cases to explain why a better middle-level approach to analysis is needed for strategic public interest-centred government science. They illustrate the importance of understanding the variety, as well as the similarity, of federal science and technology labs and agencies, and of instituting policies that reflect this diversity. The growing importance of Related Science Activities (RSA) is also explored, as well as the core trade-offs between commercial and public goods science in their mandates and their internal capacities.
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.
Download or read book Functional Foods and Biotechnology written by Kalidas Shetty and published by CRC Press. This book was released on 2019-12-23 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first of two related books that kick off the Food Biotechnology series, Functional Foods and Biotechnology: Sources of Functional Foods and Ingredients, focuses on the recent advances in the understanding of the role of cellular, metabolic, and biochemical concepts and processing that are important and relevant to improve functional foods and food ingredients targeting human health benefits. This volume explores sources of ecologically-based diversity of functional foods and food ingredients that are available to enhance diverse nutritional values and functional benefits of foods for better human health outcomes, especially focusing on emerging diet and lifestyle-linked non-communicable chronic disease (NCDs) challenges. The contributors with expertise in the field of Food Biotechnology and Functional Food Ingredients have integrated the recent advances in some common as well as novel sources of functional foods and ingredients from diverse ecological and cultural origins. Further, these chapters also highlight human health relevant bioactive profiles and associated functionalities of these health-promoting compounds, including preventative functional roles for common NCD-linked health benefits. FEATURES: Provides ecological and metabolic rational to integrate novel functional food and functional ingredient sources in wider health-focused food system innovations. Examines the value-added role of select functional foods and food ingredients to improve NCD-linked health benefits such as type-2 diabetes, cardiovascular disease, and human gut improvement Includes insights on system-based solutions to advance climate resilient and health focused food diversity based on diverse biotechnological approaches to design and integrate functional food and food ingredient sources Overall, the rationale of this book series is focused on Metabolic-Driven Rationale to Advance Biotechnological Approaches for Functional Foods, the synopsis of which is presented as the Introduction chapter, which is followed by a chapter on current understanding about regulatory guidelines for health claims of functional foods and food ingredients. Special topics on nonnutritive sweeteners, caroteneprotein from seafood waste, and Xylooligosaccharides as functional food ingredients for health-focused dietary applications are integrated in this book. Additionally, ecologically and metabolically-driven functional roles of common food sources such as corn, and barley and some novel food sources, such as ancient emmer wheat, black soybean, fava bean, herbs from Lamiaceae and functional protein ingredients and minerals from Lemnaceae are also highlighted in this volume. The overall goal is to provide insights on role of these functional food and ingredient sources for their integration in wider health-focused food systems, which will help food scientists, food industry personnel, nutritionists, crop science researchers, public health professionals, and policy makers to make appropriate decisions and to formulate strategies for improving health and well-being. A related book focuses on biological and metabolically driven mobilization of functional bioactives and ingredients and their analysis that is relevant in health and wellness.
Download or read book Microbial Enzyme Technology in Food Applications written by Ramesh C. Ray and published by CRC Press. This book was released on 2017-03-27 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of food processing is to produce food that is palatable and tastes good, extend its shelf-life, increase the variety, and maintain the nutritional and healthcare quality of food. To achieve favorable processing conditions and for the safety of the food to be consumed, use of food grade microbial enzymes or microbes (being the natural biocatalysts) is imperative. This book discusses the uses of enzymes in conventional and non-conventional food and beverage processing as well as in dairy processing, brewing, bakery and wine making. Apart from conventional uses, the development of bioprocessing tools and techniques have significantly expanded the potential for extensive application of enzymes such as in production of bioactive peptides, oligosaccharides and lipids, flavor and colorants. Some of these developments include extended use of the biocatalysts (as immobilized/encapsulated enzymes), microbes (both natural and genetically modified) as sources for bulk enzymes, solid state fermentation technology for enzyme production. Extremophiles and marine microorganisms are another source of food grade enzymes. The book throws light on potential applications of microbial enzymes to expand the base of food processing industries.
Download or read book Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 2017-12-01 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. - Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond - Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different - Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated - Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
Download or read book Science and Social Context written by Lisa N. Mills and published by McGill-Queen's Press - MQUP. This book was released on 2002-05-28 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: She examines the decision-making processes at Monsanto that led to their making the drug available and discusses corporate, academic, and regulatory decision-making in the context of a restructured global political economy for agriculture. Mills shows that there was consensus about the scientific evidence but interpretation of that evidence differed depending on the context from which it was viewed. Scientists who analysed it for regulatory bodies interpreted it differently than scientists in corporate or academic institutions, and scientists in Canada and Europe interpreted it differently than those in the United States. In the United States it was assumed that any problems arising from its use could be taken care of within the existing dairy system; in Canada and Europe these problems were regarded as legitimate animal welfare issues. While all regulatory bodies agreed that human health problems were unlikely, in Canada the Health Protection Branch questioned this, but ultimately rejected the drug on animal health grounds.
Download or read book Mad Cows and Mother s Milk Second Edition written by William Leiss and published by McGill-Queen's Press - MQUP. This book was released on 2004-11-25 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Communicating the nature and consequences of environmental and health risks is still one of the most problematic areas of public policy in Western democracies. "Mad Cows and Mother's Milk" outlines the crucial role of risk management in dealing with public controversies and analyses risk communication practice and malpractice to provide a set of lessons for risk managers and communicators. This second edition adds new case studies on mad cow disease in North America, climate change, and genetics technologies. The first of the new case studies brings the story of the Bovine Spongiform Encephalopathy (BSE) outbreak in the United Kingdom in the 1980s up-to-date. Mad cow disease is still being discovered in UK herds and cases of mad cow disease have been found in twenty countries across the European continent and as far away as Japan with devastating consequences for the food industry. BSE has now been discovered on the North American continent in two cows born in Canada. The original cause of these two new cases is almost certainly importation of infected cattle, cattle feed, or both from Britain. Canadian government regulators and those in the cattle industry have failed to correctly assess the risks of the disease in the Canadian herd, take the precautionary measures needed to prevent the spread of disease, and communicate risks and precautionary measures to the public. The second new study deals with global warming. Not only is every aspect of this risk debate both contentious and difficult for the public to understand but the potential consequences of the risks extend all the way to global catastrophe for human civilization. A new chapter outlines the many dimensions of risk debate in the context of the need for effective and sustained dialogue by an informed public. The last new case study provides an introduction to genomic science, which is placed in the context of both the health benefits expected from genetic manipulation and some of the risk factors associated with it. One example is gene therapy, which can be used to eliminate inherited genetic diseases (i.e. cystic fibrosis), enhance human traits (i.e. athletic performance), and perhaps double life-spans. Gene technologies are relevant to some of the most fundamental human values. This new chapter suggests that we must think about the range of new risks introduced by these technologies as well as the potential benefits - and that we should do this collective thinking soon, since, given the furious pace of genomics discoveries, the possibilities will be with us sooner than we imagine. All of the case studies emphasize the need for effective communication about risks to allow effective dialogue by informed publics on health and environmental risks.
