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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.
"The authors review a number of studies on the effectiveness of utility regulatory agency and governance arrangements for the electricity industry, particularly for developing countries. They discuss governance criteria and their measurement, both legal frameworks and surveys of regulatory practice. They also discuss the results from econometric studies of effectiveness for regulatory agencies in the electricity and telecommunications industries and compare these with the results from econometric studies of independent central banks and their governance. The authors conclude with a discussion of policy implications and of priorities for information collection to improve understanding of these issues. "--World Bank web site.
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
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.
This guide helps officials use perception surveys for evaluating and communicating progress in regulatory reform. It explains the challenges involved in the design and use of business and citizen perception surveys – and ways to overcome them.
Abstract: "The authors assess for 28 developing countries over the period 1980-2001 whether the existence of a regulatory law and higher quality regulatory governance are significantly associated with superior electricity outcomes. Their analysis draws on theoretical and empirical work on the impact of independent central banks and of developing country telecommunications regulators. The authors' empirical analysis concludes that a regulatory law and higher quality governance are positively and significantly associated with higher per capita generation capacity levels. In addition, this positive impact continues to increase for at least three years and probably for over 10 years as experience develops and regulatory reputation grows. The results are robust to alternative dynamic specifications and show no sign of any significant endogeneity "--World Bank web site.
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.
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).