Fundamentals of Regulatory Design

Fundamentals of Regulatory Design PDF Author: Malcolm Sparrow
Publisher:
ISBN:
Category :
Languages : en
Pages : 144

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Book Description
Subject: The modern regulatory world is crowded with ideas about different regulatory approaches including, among others: performance-based regulation, self-regulation, light-touch regulation, right-touch regulation, safety management systems, 3rd party regulation, co-regulation, prescriptive regulation, risk-based regulation, a harm-reduction approach, problem-solving, and responsive regulation. Are these various terms merely rhetorical, or aspirational? Do they signal the political preferences of the times? Which of them actually affect operations? Professional regulators--along with everyone else in the risk-control business--face a complex array of choices when they design (or redesign) their strategies and structures, programs, work-flows, relationships, and day-to-day operations. What regulators choose to do, and how they choose to do it, greatly affects their effectiveness, as well as the quality of life in a democracy. This book tackles five major design issues that affect all regulators (and can be applied by anyone else in the risk-control business). It demystifies the various labels and vogue prescriptions for regulatory conduct, clarifies the options, and generates a range of distinct ideas about what it might mean to be a "risk-based regulator." Audience: This book is designed primarily for regulatory practitioners, but will be relevant for other professionals whose roles include risk-management and harm-reduction. In the public sector, this includes law-enforcement and public-safety organizations, as well as security and intelligence agencies. In the private sector it includes compliance managers, safety officers and risk-managers. In the not-for-profit sector this includes any organization that takes on, or contributes to, harm-reduction missions. Author: Professor Malcolm K. Sparrow, of Harvard's Kennedy School of Government, has been working with senior officials in regulatory and enforcement agencies for over 30 years. Prior to joining Harvard's faculty in 1988, he served ten years with the British Police Service, rising to the rank of Detective Chief Inspector. He has authored eight other books, including The Regulatory Craft (Brookings, 2000) and The Character of Harms (Cambridge University Press, 2008). He chairs Harvard's Executive Program: "Strategic Management of Regulatory & Enforcement Agencies." Contents: This book is designed, in the context of a pandemic, to substitute for five core lectures/discussions that would normally be delivered face-to-face in executive-level courses and workshops. Professor Sparrow offers these lectures here in a comfortably accessible and conversational style. Each chapter describes a different dimension of choice, inviting readers to assess their own organization's history and habits as a precursor to figuring out whether, looking forward, some adjustment is warranted or desirable. Each chapter contains a collection of "Frequently Asked Questions" reflecting practitioners' common queries about the concepts presented, and ends with a "Diagnostic Exercise" (a set of probing questions) that readers can use, perhaps with colleagues in a book-group, to apply the analysis in their own setting. Online Teaching: Individual chapters can be assigned as "asynchronous study assignments" for courses on regulatory practice. Students, feeling "all screened out," may appreciate the availability of the paperback edition.

Fundamentals of Regulatory Design

Fundamentals of Regulatory Design PDF Author: Malcolm Sparrow
Publisher:
ISBN:
Category :
Languages : en
Pages : 144

Get Book Here

Book Description
Subject: The modern regulatory world is crowded with ideas about different regulatory approaches including, among others: performance-based regulation, self-regulation, light-touch regulation, right-touch regulation, safety management systems, 3rd party regulation, co-regulation, prescriptive regulation, risk-based regulation, a harm-reduction approach, problem-solving, and responsive regulation. Are these various terms merely rhetorical, or aspirational? Do they signal the political preferences of the times? Which of them actually affect operations? Professional regulators--along with everyone else in the risk-control business--face a complex array of choices when they design (or redesign) their strategies and structures, programs, work-flows, relationships, and day-to-day operations. What regulators choose to do, and how they choose to do it, greatly affects their effectiveness, as well as the quality of life in a democracy. This book tackles five major design issues that affect all regulators (and can be applied by anyone else in the risk-control business). It demystifies the various labels and vogue prescriptions for regulatory conduct, clarifies the options, and generates a range of distinct ideas about what it might mean to be a "risk-based regulator." Audience: This book is designed primarily for regulatory practitioners, but will be relevant for other professionals whose roles include risk-management and harm-reduction. In the public sector, this includes law-enforcement and public-safety organizations, as well as security and intelligence agencies. In the private sector it includes compliance managers, safety officers and risk-managers. In the not-for-profit sector this includes any organization that takes on, or contributes to, harm-reduction missions. Author: Professor Malcolm K. Sparrow, of Harvard's Kennedy School of Government, has been working with senior officials in regulatory and enforcement agencies for over 30 years. Prior to joining Harvard's faculty in 1988, he served ten years with the British Police Service, rising to the rank of Detective Chief Inspector. He has authored eight other books, including The Regulatory Craft (Brookings, 2000) and The Character of Harms (Cambridge University Press, 2008). He chairs Harvard's Executive Program: "Strategic Management of Regulatory & Enforcement Agencies." Contents: This book is designed, in the context of a pandemic, to substitute for five core lectures/discussions that would normally be delivered face-to-face in executive-level courses and workshops. Professor Sparrow offers these lectures here in a comfortably accessible and conversational style. Each chapter describes a different dimension of choice, inviting readers to assess their own organization's history and habits as a precursor to figuring out whether, looking forward, some adjustment is warranted or desirable. Each chapter contains a collection of "Frequently Asked Questions" reflecting practitioners' common queries about the concepts presented, and ends with a "Diagnostic Exercise" (a set of probing questions) that readers can use, perhaps with colleagues in a book-group, to apply the analysis in their own setting. Online Teaching: Individual chapters can be assigned as "asynchronous study assignments" for courses on regulatory practice. Students, feeling "all screened out," may appreciate the availability of the paperback edition.

National Audit Office - Charity Commission: The Regulatory Effectiveness of the Charity Commossion - HC 813

National Audit Office - Charity Commission: The Regulatory Effectiveness of the Charity Commossion - HC 813 PDF Author: Great Britain: National Audit Office
Publisher: The Stationery Office
ISBN: 9780102987164
Category : Social Science
Languages : en
Pages : 52

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Book Description
The Charity Commission is not regulating charities effectively and there is a gap between what the public expects of the Commission and what it actually does. The NAO has concluded that the Commission does not do enough to identify and tackle abuse of charitable status. Between 2007-08 and 2013-14, the Commission's annual budget fell 40 per cent in real terms to £22.7 million but the number of main registered charities has remained fairly constant at around 160,000. In response to budget cuts, the Commission has reviewed how it works and successfully reduced demand for its services, but it has not identified what budget it would need to regulate effectively. The Commission makes little use of its enforcement powers, for example suspending only two trustees and removing none in 2012-13. And it can be slow to act when investigating regulatory concerns. The NAO found cases where periods of several months passed during which the Commission took no action. Furthermore, the Charity Commission does not take tough enough action in some of the most serious regulatory cases. It is also reactive rather than proactive, making insufficient use of the information it holds to identify risk. The Charity Commission needs to think radically about alternative ways of meeting its objectives with constrained resources. It also needs to make greater use of its statutory powers in line with its objective of maintaining confidence in the sector; and develop an approach to identify and deal with those few trustees who deliberately abuse charitable status. This report publishes alongside another NAO report, the Cup Trust.

Valuing Health for Regulatory Cost-Effectiveness Analysis

Valuing Health for Regulatory Cost-Effectiveness Analysis PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309164842
Category : Medical
Languages : en
Pages : 382

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Book Description
Promoting human health and safety by reducing exposures to risks and harms through regulatory interventions is among the most important responsibilities of the government. Such efforts encompass a wide array of activities in many different contexts: improving air and water quality; safeguarding the food supply; reducing the risk of injury on the job, in transportation, and from consumer products; and minimizing exposure to toxic chemicals. Estimating the magnitude of the expected health and longevity benefits and reductions in mortality, morbidity, and injury risks helps policy makers decide whether particular interventions merit the expected costs associated with achieving these benefits and inform their choices among alternative strategies. Valuing Health for Regulatory Cost-Effectiveness Analysis provides useful recommendations for how to measure health-related quality of- life impacts for diverse public health, safety, and environmental regulations. Public decision makers, regulatory analysts, scholars, and students in the field will find this an essential review text. It will become a standard reference for all government agencies and those consultants and contractors who support the work of regulatory programs.

An Exploration of Effectiveness in the Regulation of Federal Depository Institutions, 1989–2008

An Exploration of Effectiveness in the Regulation of Federal Depository Institutions, 1989–2008 PDF Author: Mike Potter
Publisher: Lexington Books
ISBN: 0739179365
Category : Political Science
Languages : en
Pages : 146

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Book Description
This book is an applied study of regulatory policymaking. It investigates the qualities that make regulators effective and concludes that effective regulators balance a public interest orientation with openness towards their regulated communities.

Management of Animal Care and Use Programs in Research, Education, and Testing

Management of Animal Care and Use Programs in Research, Education, and Testing PDF Author: Robert H. Weichbrod
Publisher: CRC Press
ISBN: 1498748457
Category : Medical
Languages : en
Pages : 917

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Book Description
AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

Innovation and the State

Innovation and the State PDF Author: Cristie Ford
Publisher: Cambridge University Press
ISBN: 1108514669
Category : Law
Languages : en
Pages : 374

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Book Description
From social media to mortgage-backed securities, innovation carries both risk and opportunity. Groups of people win, and lose, when innovation changes the ground rules. Looking beyond formal politics, this new book by Cristie Ford argues that we need to recognize innovation, and financial innovation in particular, as a central challenge for regulation. Regulation is at the leading edge of politics and policy in ways that we have not yet fully grasped. Seemingly innocuous regulatory design choices have clear and profound practical ramifications for many of our most cherished social commitments. Innovation is a complex phenomenon that needs to be understood not only in technical terms, but also in human ones. Using financial regulation as her primary example, Ford argues for a fresh approach to regulation, which recognizes innovation for the regulatory challenge that it is, and which binds our cherished social values and our regulatory tools ever more tightly together.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process PDF 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.

OECD Reviews of Regulatory Reform Risk and Regulatory Policy Improving the Governance of Risk

OECD Reviews of Regulatory Reform Risk and Regulatory Policy Improving the Governance of Risk PDF 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.

Enhancing Board Effectiveness

Enhancing Board Effectiveness PDF Author: Franklin N. Ngwu
Publisher: Routledge
ISBN: 1351689061
Category : Business & Economics
Languages : en
Pages : 416

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Book Description
Enhancing Board Effectiveness seeks to examine the conceptualization and role of the board in a variety of contexts and articulate solutions for improving the effectiveness of the board, especially in developing and emerging markets. Enhancing Board Effectiveness with therefore address the following central questions: To what extent is the concept and role of the board evolving? What rights, powers, responsibilities and other contemporary and historical experiences can enhance the effectiveness of the board, especially in the particular contexts of developing and emerging markets? What socio-economic, political, regulatory and institutional factors/actors influence the effectiveness of the board and how can the policies and practices of such actors exert such influences? In what ways can a reconstructed concept of the board serve as a tool for theoretical, analytical, regulatory and pragmatic assessment of its effectiveness? In examining this issues, Enhancing Board Effectiveness will investigate theoretical, socio-economic, historical, empirical, regulatory, comparative and inter-disciplinary approaches. Academics in the relevant fields of accounting, behavioural psychology/economics, development studies, financial regulation, law and management/organizational studies, political economy and, public administration will find this book of high interest.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World PDF 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.