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Author: Paul S. Fischbeck
Publisher: Routledge
ISBN: 1136522638
Category : Health & Fitness
Languages : en
Pages : 480
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Book Description
Is there potential for a U.S. regulatory system that is more efficient and effective? Or is the future likely to involve 'paralysis by analysis'? Improving Regulation considers the challenges faced by the regulatory system as society and technology change, and our knowledge about the effects of our activities on human and planetary health becomes more sophisticated. While considering the difficulty in linking regulatory design and performance, Improving Regulation makes the case for empowering regulatory analysis. Studying applications as diverse as fire protection, air and water pollution, and genetics, its contributors examine the strategies of different stakeholders in today's complex policymaking environment. With a focus on the behavior of institutions and people, they consider the impact that organizational politics, science, technology, and performance have on regulation. They explore the role of technology in creating and reducing uncertainty, the costs of control, the potential involvement of previously unregulated sectors, and the contentious public debates about fairness and participation in regulatory policy. Arguing that the success of many regulations depends upon their acceptance by the public, Fischbeck, Farrow, and their contributors offer extensive, inductive evidence on the art of regulatory analysis. The resulting book provides 'real world' examples of regulation, and a demonstration of how to synthesize analytical skills with a knowledge of physical and social processes.
Author: Paul S. Fischbeck
Publisher: Routledge
ISBN: 1136522638
Category : Health & Fitness
Languages : en
Pages : 480
Get Book Here
Book Description
Is there potential for a U.S. regulatory system that is more efficient and effective? Or is the future likely to involve 'paralysis by analysis'? Improving Regulation considers the challenges faced by the regulatory system as society and technology change, and our knowledge about the effects of our activities on human and planetary health becomes more sophisticated. While considering the difficulty in linking regulatory design and performance, Improving Regulation makes the case for empowering regulatory analysis. Studying applications as diverse as fire protection, air and water pollution, and genetics, its contributors examine the strategies of different stakeholders in today's complex policymaking environment. With a focus on the behavior of institutions and people, they consider the impact that organizational politics, science, technology, and performance have on regulation. They explore the role of technology in creating and reducing uncertainty, the costs of control, the potential involvement of previously unregulated sectors, and the contentious public debates about fairness and participation in regulatory policy. Arguing that the success of many regulations depends upon their acceptance by the public, Fischbeck, Farrow, and their contributors offer extensive, inductive evidence on the art of regulatory analysis. The resulting book provides 'real world' examples of regulation, and a demonstration of how to synthesize analytical skills with a knowledge of physical and social processes.
Author: National Performance Review (U.S.)
Publisher:
ISBN:
Category : Administrative procedure
Languages : en
Pages : 92
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Book Description
Author: Lorenza Jachia
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 124
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Book Description
Recent years have been marked by many catastrophic events both natural and man-made. Close interconnections mean that the impact of these crises has been felt throughout the world. Although many tools have been developed to manage risks successfully, there can be no doubt that many of the losses we have recently witnessed could have been prevented, or minimised, in the context of an effective and well-balanced regulatory system. The goal of this publication is to provide insights and recommendations for policymakers on designing regulatory systems that result in an efficient, effective and transparent management of risks. This is a practical book. It introduces a holistic model of a regulatory system, function by function and with real-life examples, which is based on the objective of managing risks effectively.
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: 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 Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309670438
Category : Medical
Languages : en
Pages : 243
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Book Description
Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.
Author: Pan American Health Organization
Publisher: Pan American Health Organization
ISBN: 9789275123430
Category :
Languages : en
Pages : 134
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Book Description
Improving access to safe, effective, and quality medicines and other health technologies is a critical public health priority and a fundamental requisite for universal health. National regulatory systems play a key part in a country's health system by overseeing the safety, quality, and efficacy of all health technologies, including pharmaceuticals, vaccines, blood and blood products, and medical devices, among others. The aim of this document is to better understand the regulatory landscape of the Americas, with an emphasis on Latin American National Regulatory Authorities of Reference. This report presents data and analysis corresponding to essential regulatory functions and systems foundations to understand current practices, identify critical issues, and present a series of recommendations for action. The report also includes an overview of the market outlook and economic integration mechanisms in the Americas and their influence on regulatory policy and pharmaceutical trade. In addition, the report includes a supplement to describe salient regulatory emergency responses to the COVID-19 pandemic in the Americas. Through this report, the Pan American Health Organization aims to increase the understanding of national regulatory remits and capacity in the Americas, raise awareness and appreciation of the regional regulatory progress and challenges, identify the regulatory issues emerging markets will bring, and highlight opportunities for evidence-based regulatory system strengthening.
Author: National Performance Review (U.S.)
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 92
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Book Description
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: 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 ...
