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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.
Are political understandings of bureaucracy incompatible with Weberian features of administrative neutrality? In examining the question of whether interest groups and elected officials are able to influence how government agencies implement the law, this book identifies the political origins of bureaucratic neutrality. In bridging the traditional gap between questions of internal management (public administration) and external politics (political science), Huber argues that 'strategic neutrality' allows bureaucratic leaders to both manage their subordinates and sustain political support. By analyzing the OSH Act of 1970, Huber demonstrates the political origins and benefits of administrative neutrality, and contrasts it with apolitical and unconstrained administrative implementation. Historical analysis, interviews with field-level bureaucrats and their supervisors, and quantitative analysis provide a rich understanding of the twin difficulties agency leaders face as political actors and personnel managers.
This book transcends current debate on government regulation by lucidly outlining how regulations can be a fruitful combination of persuasion and sanctions. The regulation of business by the United States government is often ineffective despite being more adversarial in tone than in other nations. The authors draw on both empirical studies of regulation from around the world and modern game theory to illustrate innovative solutions to this problem. Their ideas include an argument for the empowerment of private and public interest groups in the regulatory process and a provocative discussion of how the government can support and encourage industry self-regulation.
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.
The Brewers Association's Guide to Starting Your Own Brewery distills the wisdom of craft brewing veteran Dick Cantwell into one text that delivers essential industry insight. American craft brewers have always exhibited a sense of community and collegiality but the success of the industry is embodied by the production of consistently high-quality beer at community-oriented breweries. This book is an indispensable resource for aspiring brewery owners to turn that vision into reality. At every level, brewing is about careful planning and execution of processes. The author shows that this is no different when starting a brewery. Cantwell walks the reader through initial planning, from site selection, size, staffing levels, your brewery concept, and dealing with delays, to business planning and raising capital. Regulatory and legal issues are discussed—not least a brewery's obligations to the inland revenue service—along with strategies essential for starting and growing your operation, such as production and sales planning and brewery expansion either on site or opening new locations. The author includes several example business plans that are explored in detail, and peppers the book with his own personal and hard-won insights on everything from guerilla marketing to applying epoxy resin flooring. Within this big picture, the author weaves in critical aspects like brand identity, marketing, quality assurance, and distribution, not to mention details like equipment options, securing ingredients, and installing flooring and drainage that will stand up to the demands of a busy brewery. Finally, once your brewery opens its doors, the process of brewing needs to continue smoothly. You need to plan and adapt your brand portfolio, operate sustainably, dispose of wastewater correctly, and package and present your product in a way that will appeal to customers. Craft breweries pride themselves on conscientious operation, maintaining the safety of their staff and operating responsibly within their community, all the while being profitable. From concept to operation, this book gets you on the right track to succeed in one of today's most dynamic industries.
Simpler government arrived four years ago. It helped put money in your pocket. It saved hours of your time. It improved your children’s diet, lengthened your life span, and benefited businesses large and small. It did so by issuing fewer regulations, by insisting on smarter regulations, and by eliminating or improving old regulations. Cass R. Sunstein, as administrator of the most powerful White House office you’ve never heard of, oversaw it and explains how it works, why government will never be the same again (thank goodness), and what must happen in the future. Cutting-edge research in behavioral economics has influenced business and politics. Long at the forefront of that research, Sunstein, for three years President Obama’s “regulatory czar” heading the White House Office of Information and Regulatory Affairs, oversaw a far-reaching restructuring of America’s regulatory state. In this highly anticipated book, Sunstein pulls back the curtain to show what was done, why Americans are better off as a result, and what the future has in store. The evidence is all around you, and more is coming soon. Simplified mortgages and student loan applications. Scorecards for colleges and universities. Improved labeling of food and energy-efficient appliances and cars. Calories printed on chain restaurant menus. Healthier food in public schools. Backed by historic executive orders ensuring transparency and accountability, simpler government can be found in new initiatives that save money and time, improve health, and lengthen lives. Simpler: The Future of Government will transform what you think government can and should accomplish.
Innovative, interdisciplinary, practitioner-oriented insights into the key challenges faced in addressing the services trade liberalization and domestic regulation interface.
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.