The Regulatory Craft tackles one of the most pressing public policy issues of our time—the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities—which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation—the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.

The Regulatory Craft tackles one of the most pressing public policy issues of our time —the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities —which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation —the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.

As an experiment in reconnecting academia to the broader democracy, this work is designed to invigorate public policy debate by rededicating academic work to the pursuit of solutions to society's great problems.

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

Political discourse in much of the world remains mired in simplistic ideological dichotomies of market fundamentalism for efficiency versus substantial socialism for equity. Contemporary public policy design is far more sophisticated. It blends market, government and community tools to simultaneously achieve both equity and efficiency. Unlike in the twentieth century, this design is increasingly grounded in a deep evidence base derived by way of rigorous empirical techniques. A new paradigm is emerging: hybrid policies. This volume provides a thorough introduction to this technical side of public policy analysis and development. It demonstrates that it is possible to go beyond ideology, and find there some powerful answers to our most pressing problems. An international team of experts, many of whom have experience with the design or implementation of hybrid policies, helps cover the behavioural, institutional and regulatory theories that inform the choice of policy objectives and lead the initial conception of solutions. They explain the reasons why we need evidence-based public policy and the state-of-the-art empirical techniques involved in its development. And they analyse a range of in-depth case studies from industrial relations to health care to illustrate how hybrids can intermingle the strengths of governments, markets and the community to combat the weaknesses of each and arrive at bipartisan outcomes. Hybrid Public Policy Innovations is geared to scholars and practitioners of public policy administration and management who desire to understand the analytical reasons why policies are designed the way they are, and the purpose of evidence-gathering frameworks attached to policies at implementation.

How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.