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Handbook of Regulatory Authorities by Maggetti, Martino,Di Mascio, Fabrizio,Natalini, Alessandro Pdf
Featuring a comprehensive analytical collection of interdisciplinary research on regulatory authorities, this innovative Handbook combines contributions from leading scholars and regulatory practitioners to present the fundamental theoretical concepts, empirical achievements and challenges in the contemporary study of regulatory authorities.
Handbook for Evaluating Infrastructure Regulatory Systems by Ashley C. Brown,Jon Stern,Bernard William Tenenbaum,Defne Gencer Pdf
More than 200 new infrastructure regulators have been created around the world in the last 15 years. They were established to encourage clear and sustainable long-term economic and legal commitments by governments and investors to encourage new investment to benefit existing and new customers. There is now considerable evidence that both investors and consumers-the two groups that were supposed to have benefited from these new regulatory systems-have often been disappointed with their performance. The fundamental premise of this book is that regulatory systems can be successfully reformed only if there are independent, objective and public evaluations of their performance. Just as one goes to a medical doctor for a regular health checkup, it is clear that infrastructure regulation would also benefit from periodic checkups. This book provides a general framework as well as detailed practical guidance on how to perform such "regulatory checkups."
Handbook of Regulatory Impact Assessment by Claire A. Dunlop,Claudio M. Radaelli Pdf
Regulatory impact assessment (RIA) is the main instrument used by governments and regulators to appraise the likely effects of their policy proposals. This pioneering Handbook provides a comparative and comprehensive account of this tool, situating it in the relevant theoretical traditions and scrutinizing its use across countries, policy sectors and policy instruments. Comprising six parts, university researchers, international consultants and practitioners working in international organizations examine regulatory impact assessment from many perspectives, which include: • research traditions in the social sciences • implementation, regulatory indicators and effects • tools and dimensions such as courts and gender • sectoral case studies including environment, enterprise and international development • international diffusion in the European Union (EU), Americas, Asia and developing countries • appraisal, training and education. With its wealth of detail and lessons to be learned, the Handbook of Regulatory Impact Assessment will undoubtedly be of great value to practitioners and scholars working in governance, political science and socio-legal studies.
Handbook on the Politics of Regulation by David Levi-Faur Pdf
'Political science has leap-frogged law, economics, and sociology to become the dominant discipline contributing to regulatory studies. David Levi-Faur's volume taps the rich veins of regulatory scholarship that have made this the case. It brings together the talented new network of politics scholars intrigued by the importance of the changing nature of state and non-state regulation. Their fresh insights complement important new work by established stars of the field. Definitely a book to have on your shelf when in search of exciting theoretical approaches to politics.' – John Braithwaite, Australian National University '"Regulation", in its manifold forms, is the central process of contemporary governance, as it seeks to blend the dynamism of market economies with responsiveness to political and normative demands for health, safety, environmental protection, and fairness. Understanding regulation's varieties, vulnerabilities, and virtues has become a significant focus of academic research and theory. This volume provides an extraordinary survey of research in that field – a survey remarkable in its comprehensiveness, outstanding in the quality of the contributions by leading regulatory scholars from different nations and academic disciplines.' – Robert A. Kagan, University of California, Berkeley, US 'An authoritative collection by a range of contributors with outstanding reputations in the field.' – Michael Moran, WJM Mackenzie Professor of Government 'This is an extraordinarily useful one-stop-shop for a wide range of traditions and approaches to the political aspects of regulation. David Levi-Faur has assembled a fine collection that by reporting on the state of the art also shows the way ahead for a discipline that has to capture and explain dramatic changes in real-world regulatory philosophies and policies.' – Claudio Radaelli, University of Exeter, UK 'This is an unusually impressive edited volume. Its contributors include the leading academic experts on government regulation from around the world. Its several clearly-written and informative essays address the most important topics, issues, and debates that have engaged students of regulatory politics. I strongly recommend this volume to anyone interested in understanding the breadth and depth of contemporary scholarship on the political dimensions of regulation.' – David Vogel, University of California, Berkeley, US This unique Handbook offers the most up-to-date and comprehensive, state-of-the-art reviews of the politics of regulation. It presents and discusses the core theories and concepts of regulation in response to the rise of the regulatory state and regulatory capitalism, and in the context of the 'golden age of regulation'. Its ten sections include forty-nine chapters covering issues as diverse and varied as: theories of regulation; historical perspectives on regulation; regulation of old and new media; risk regulation, enforcement and compliance; better regulation; civil regulation; European regulatory governance; and global regulation. As a whole, it provides an essential point of reference for all those working on the political, social, and economic aspects of regulation. This comprehensive resource will be of immense value to scholars and policymakers in numerous fields and disciplines including political science, public policy and administration, international relations, regulation, international law, business and politics, European studies, regional studies, and development studies.
The Oxford Handbook of Regulation by Robert Baldwin,Martin Cave,Martin Lodge Pdf
Regulation is often thought of as an activity that restricts behaviour and prevents the occurrence of certain undesirable activities, but the influence of regulation can also be enabling or facilitative, as when a market could potentially be chaotic if uncontrolled. This Handbook provides a clear and authoritative discussion of the major trends and issues in regulation over the last thirty years, together with an outline of prospective developments. It brings together contributions from leading scholars from a range of disciplines and countries. Each chapter offers a broad overview of key current issues and provides an analysis of different perspectives on those issues. Experiences in different jurisdictions and insights from various disciplines are drawn upon, and particular attention is paid to the challenges that are encountered when specific approaches are applied in practice. Contributors develop their own distinctive arguments relating to the central issues in regulation and apply scholarly rigour and clear writing to matters of high policy-relevance. The essays are original, accessible, and agenda-setting, and the Handbook will be essential reading both to students and researchers and to with regulatory and regulated professionals.
Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Functions and Processes of the Regulatory Body for Safety by International Atomic Energy Agency Pdf
This Safety Guide provides recommendations on meeting the requirements of IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety, on the regulatory body's core functions and associated regulatory processes. This guidance is particularly important for regulatory bodies having responsibilities covering a range of facilities and activities that give rise to radiation risks and the important organizational interfaces between various regulatory authorities, which require effective coordination and cooperation. It promotes a consistent approach to regulation and specifically addresses the release of facilities and activities from regulatory control including sites, buildings, equipment and material. The publication is intended to be used mainly by regulatory bodies but will also be useful for governments that are developing a regulatory framework for safety. It will also assist authorized parties and others dealing with radiation sources in understanding regulatory procedures, processes and expectations.
The Handbook of Environmental Compliance in Ontario by John-David Phyper,Brett Ibbotson Pdf
The challenges of knowing and understanding environmental legislation in Ontario have never been more demanding. Regulations are being revised, updated and expanded. Major shifts are occurring in the philosophy of regulatory agencies, the methods they use and the division of responsibilities among the three levels of government. From small manufacturing businesses to huge conglomerates, today's companies and organizations need to design and implement environmental management practices that will satisfy these shifting requirements and expectations. The Handbook of Environmental Compliance in Ontario covers the changing nature of environmental compliance in a succinct and direct manner. Authors John-David Phyper and Brett Ibbotson provide you with practical information and insight into Ontario's environmental regulatory requirements. They cover all aspects, including: Air quality and atmospheric emissions Water quality and liquid effluents Waste management and transportation Site assessment and environmental audits Spills and emergency response planning From environmental managers and engineers to lawyers and regulators to students, teachers and consultants, you'll find up-to-date information to ensure you are in sync with today's legislation and best practices.
Handbook on Product Standards and International Trade by James J. Nedumpara,Satwik Shekhar,Akshaya Venkataraman Pdf
Global Trade Law Series, Volume 55 India, one of the world’s foremost trading nations, exhibits a particularly complex regulatory landscape with a variety of standard-setting bodies, regulators, accreditation and certification bodies, inspection agencies, as well as several state-level regulators. This is the first book to extensively describe the nature of standard-setting processes in India and the key agencies involved with this task, greatly clarifying the scope of market opportunities in the country. Lucid contributions from experienced practitioners and regulators with first-hand experience in formulating and advising on standards-related issues in international trade help disentangle the web of laws, regulations, operations, and functions of India’s standard setters in governmental, non-governmental, and industry contexts. The chapters describe how standards apply to such crucial trade aspects as the following: conformity assessment practice and procedure; environmental, ethical, social, and safety issues; import bans and import licensing; certification and labelling measures; mutual recognition agreements; food safety; and standardisation of the digital economy. The book is drafted throughout in an easy-to-read style, with numerous tables, flowcharts, and figures illustrating step-by-step compliance procedures. Informative annexes guide the reader to relevant agencies and identify their roles and responsibilities. This book provides a clear and concise guide to the operations, functions, and compliance and documentation requirements of India’s standard-setting and regulatory bodies across all sectors and products, and thus will serve as an unmatched guide for manufacturers, traders, and exporters operating in the Indian market or seeking to export to India. It will also serve as a useful Handbook to policymakers, academics, and researchers interested in understanding the role of standard-setting bodies in the field of international trade.
Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Pdf
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Does Regulation Kill Jobs? by Cary Coglianese,Adam M. Finkel,Christopher Carrigan Pdf
As millions of Americans struggle to find work in the wake of the Great Recession, politicians from both parties look to regulation in search of an economic cure. Some claim that burdensome regulations undermine private sector competitiveness and job growth, while others argue that tough new regulations actually create jobs at the same time that they provide other benefits. Does Regulation Kill Jobs? reveals the complex reality of regulation that supports neither partisan view. Leading legal scholars, economists, political scientists, and policy analysts show that individual regulations can at times induce employment shifts across firms, sectors, and regions—but regulation overall is neither a prime job killer nor a key job creator. The challenge for policymakers is to look carefully at individual regulatory proposals to discern any job shifting they may cause and then to make regulatory decisions sensitive to anticipated employment effects. Drawing on their analyses, contributors recommend methods for obtaining better estimates of job impacts when evaluating regulatory costs and benefits. They also assess possible ways of reforming regulatory institutions and processes to take better account of employment effects in policy decision-making. Does Regulation Kills Jobs? tackles what has become a heated partisan issue with exactly the kind of careful analysis policymakers need in order to make better policy decisions, providing insights that will benefit both politicians and citizens who seek economic growth as well as the protection of public health and safety, financial security, environmental sustainability, and other civic goals. Contributors: Matthew D. Adler, Joseph E. Aldy, Christopher Carrigan, Cary Coglianese, E. Donald Elliott, Rolf Färe, Ann Ferris, Adam M. Finkel, Wayne B. Gray, Shawna Grosskopf, Michael A. Livermore, Brian F. Mannix, Jonathan S. Masur, Al McGartland, Richard Morgenstern, Carl A. Pasurka, Jr., William A. Pizer, Eric A. Posner, Lisa A. Robinson, Jason A. Schwartz, Ronald J. Shadbegian, Stuart Shapiro.
The Oxford Handbook of Financial Regulation by Niamh Moloney,Eilís Ferran,Jennifer Payne Pdf
The financial system and its regulation have undergone exponential growth and dramatic reform over the last thirty years. This period has witnessed major developments in the nature and intensity of financial markets, as well as repeated cycles of regulatory reform and development, often linked to crisis conditions. The recent financial crisis has led to unparalleled interest in financial regulation from policymakers, economists, legal practitioners, and the academic community, and has prompted large-scale regulatory reform. The Oxford Handbook of Financial Regulation is the first comprehensive, authoritative, and state of the art account of the nature of financial regulation. Written by an international team of leading scholars in the field, it takes a contextual and comparative approach to examine scholarly, policy, and regulatory developments in the past three decades. The first three parts of the Handbook address the underpinning horizontal themes which arise in financial regulation: financial systems and regulation; the organization of financial system regulation, including regional examples from the EU and the US; and the delivery of outcomes and regulatory techniques. The final three Parts address the perennial objectives of financial regulation, widely regarded as the anchors of financial regulation internationally: financial stability, market efficiency, integrity, and transparency; and consumer protection. The Oxford Handbook of Financial Regulation is an invaluable resource for scholars and students of financial regulation, economists, policy-makers and regulators.
Author : Jerry Brito,Susan E. Dudley Publisher : Mercatus Center at George Mason University Page : 130 pages File Size : 43,5 Mb Release : 2012-08-13 Category : Law ISBN : 9780983607731
Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (generic) Products by Susan Walters (Dr),Organisation mondiale de la santé Pdf
Council of Europe,European Union Agency for Fundamental Rights
Author : Council of Europe,European Union Agency for Fundamental Rights Publisher : Council of Europe Page : 402 pages File Size : 47,7 Mb Release : 2018-04-15 Category : Political Science ISBN : 9789287198495
Handbook on European data protection law by Council of Europe,European Union Agency for Fundamental Rights Pdf
The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.
