Preparing for Future Products of Biotechnology PDF Download

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231

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Book Description
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.

Author: National Performance Review (U.S.)
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 92

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Author: OECD
Publisher: OECD Publishing
ISBN: 9264311734
Category :
Languages : en
Pages : 199

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Book Description
Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169

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Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Author: OECD
Publisher: OECD Publishing
ISBN: 926408293X
Category :
Languages : en
Pages : 251

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Book Description
This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies.

Author: Food and Agriculture Organization of the United Nations
Publisher: Food & Agriculture Org.
ISBN: 9251316309
Category : Business & Economics
Languages : en
Pages : 44

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Book Description
The main objective of the tool is to propose a harmonized, objective and consensual basis to analyse the performance of a national food control system. It is intended to be used by countries as a supporting basis for self-assessment to identify priority areas of improvement and plan sequential and coordinated activities to reach expected outcomes, and by repeating the assessment on a regular basis, countries can monitor their progresses. The Tool is based on Codex principles and Guidelines for National Food Control Systems as well as other relevant Codex guidance for food control systems, which are referenced throughout the document. Its scope is given by the dual objectives quoted in Codex guidance for these systems: protect health of consumers and ensure fair practices in the food trade. This introductory volume presents the FAO/WHO Food Control System Assessment Tool, providing background to its development and outlining its main scope and objectives. It presents a thorough review of the assessment Tool structure, breaking it down into its constitutive elements (dimensions, sub-dimensions, competencies and assessment criteria). Finally, it gives an overview of the assessment approach, from the ratings to the descriptive analysis supporting the allocation of scores. The volume also contains a glossary of useful terms and the list of Codex documents referenced in the Tool.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141

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Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264116575
Category :
Languages : en
Pages : 155

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Book Description
This report encourages governments to “think big” about the relevance of regulatory policy and assesses the recent efforts of OECD countries to develop and deepen regulatory policy and governance.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264805907
Category :
Languages : en
Pages : 447

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Book Description
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Author: National Research Council
Publisher: National Academies Press
ISBN: 0309221412
Category : Science
Languages : en
Pages : 213

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Book Description
The blowout of the Macondo well on April 20, 2010, led to enormous consequences for the individuals involved in the drilling operations, and for their families. Eleven workers on the Deepwater Horizon drilling rig lost their lives and 16 others were seriously injured. There were also enormous consequences for the companies involved in the drilling operations, to the Gulf of Mexico environment, and to the economy of the region and beyond. The flow continued for nearly 3 months before the well could be completely killed, during which time, nearly 5 million barrels of oil spilled into the gulf. Macondo Well-Deepwater Horizon Blowout examines the causes of the blowout and provides a series of recommendations, for both the oil and gas industry and government regulators, intended to reduce the likelihood and impact of any future losses of well control during offshore drilling. According to this report, companies involved in offshore drilling should take a "system safety" approach to anticipating and managing possible dangers at every level of operation-from ensuring the integrity of wells to designing blowout preventers that function under all foreseeable conditions-in order to reduce the risk of another accident as catastrophic as the Deepwater Horizon explosion and oil spill. In addition, an enhanced regulatory approach should combine strong industry safety goals with mandatory oversight at critical points during drilling operations. Macondo Well-Deepwater Horizon Blowout discusses ultimate responsibility and accountability for well integrity and safety of offshore equipment, formal system safety education and training of personnel engaged in offshore drilling, and guidelines that should be established so that well designs incorporate protection against the various credible risks associated with the drilling and abandonment process. This book will be of interest to professionals in the oil and gas industry, government decision makers, environmental advocacy groups, and others who seek an understanding of the processes involved in order to ensure safety in undertakings of this nature.