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The Development Of European Regulatory Agencies
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Book Synopsis The Politics of Regulation by : Jacint Jordana
Download or read book The Politics of Regulation written by Jacint Jordana and published by Edward Elgar Publishing. This book was released on 2004-01-01 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: These changes, together with the general advance in the study of regulation, undoubtedly demand a re-evaluation of the theory of regulation, its methodologies and scope of application. This book is a perceptive investigation of recent evolutions in the manner and extent of governance through regulation. Scholars and students of comparative politics, public policy, regulation theory, institutional economics and political sociology will find it to be essential reading. It will also prove a valuable source of reference for those working or dealing with regulatory authorities and for business managers in private industries and services operating under a regulatory framework.
Book Synopsis Better Regulation Practices across the European Union by : OECD
Download or read book Better Regulation Practices across the European Union written by OECD and published by OECD Publishing. This book was released on 2019-03-19 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
Book Synopsis Europe in 12 Lessons by : Pascal Fontaine
Download or read book Europe in 12 Lessons written by Pascal Fontaine and published by . This book was released on 2017 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Refining Regulatory Regimes by : David Coen
Download or read book Refining Regulatory Regimes written by David Coen and published by Edward Elgar Publishing. This book was released on 2005-01-01 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: With regulation seeking to foster competition at the same time as also having to protect essential services, the authors investigate regulatory styles, costs of new regulatory functions and how firms in the new regulatory landscape access and influence regulatory authorities. The authors consider how EU pressures may hinder or help the functioning of new regulatory markets and the establishment of business-regulator relationships, as well as the broader policy implications for these new regulatory environments. The book also determines how regulatory authorities emerge and evolve under different state traditions and assesses, over time, the degree to which there is potential for convergence, divergence and continued differences as regulatory functions mature.
Book Synopsis The Brussels Effect by : Anu Bradford
Download or read book The Brussels Effect written by Anu Bradford and published by Oxford University Press. This book was released on 2020-01-27 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.
Download or read book Eurolegalism written by R. Daniel Kelemen and published by Harvard University Press. This book was released on 2011-04 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite western Europe's traditional disdain for the United States' "adversarial legalism," the European Union is shifting toward a very similar approach to the law, according to Daniel Kelemen. Coining the term "eurolegalism" to describe the hybrid that is now developing in Europe, he shows how the political and organizational realities of the EU make this shift inevitable. The model of regulatory law that had long predominated in western Europe was more informal and cooperative than its American counterpart. It relied less on lawyers, courts, and private enforcement, and more on opaque networks of bureaucrats and other interests that developed and implemented regulatory policies in concert. European regulators chose flexible, informal means of achieving their objectives, and counted on the courts to challenge their decisions only rarely. Regulation through litigation-central to the U.S. model-was largely absent in Europe. But that changed with the advent of the European Union. Kelemen argues that the EU's fragmented institutional structure and the priority it has put on market integration have generated political incentives and functional pressures that have moved EU policymakers to enact detailed, transparent, judicially enforceable rules-often framed as "rights"-and back them with public enforcement litigation as well as enhanced opportunities for private litigation by individuals, interest groups, and firms.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis The Oxford Handbook of Business and Government by : David Coen
Download or read book The Oxford Handbook of Business and Government written by David Coen and published by Oxford Handbooks Online. This book was released on 2010-02-25 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Business is one of the major power centres in modern society. The state seeks to check and channel that power so as to serve broader public policy objectives. However, if the way in which business is governed is ineffective or over burdensome, it may become more difficult to achieve desired goals such as economic growth or higher levels of employment. In a period of international economic crisis, the study of how business and government relate to each other in different countries isof more central importance than ever.These relationships have been studied from a number of different disciplinary perspectives - business studies, economics, economic history, law, and political science - and all of these are represented in this handbook. The first part of the book provides an introduction to the ways in which five different disciplines have approached the study of business and government. The second section, on the firm and the state, looks at how these entities interact in different settings, emphasising suchphenomena as the global firm and varieties of capitalism. The third section examines how business interacts with government in different parts of the world, including the United States, the EU, China, Japan and South America. The fourth section reviews changing patterns of market governance through aunifying theme of the role of regulation. Business-government relations can play out in divergent ways in different policy and the fifth section examines the contrasts between different key arenas such as competition policy, trade policy, training policy and environmental policy.The volume provides an authoritative overview with chapters by leading authorities on the current state of knowledge of business-government relations, but also points to ways in which this work might be developed in the future, e.g., through a political theory of the firm.
Book Synopsis Reforming the European Commission by : Michael W. Bauer
Download or read book Reforming the European Commission written by Michael W. Bauer and published by Routledge. This book was released on 2013-10-18 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many international and supranational organisations have lately been busy modernising their internal administration. But nowhere has management change received a similar amount of attention than in the case of the European Commission. Although the perception prevails that the Commission has been losing out in recent years, this vivid interest, academic as well as public, in the so-called Kinnock reform suggests that this organisation still remains "at the heart of the Union". The proposition of this book thus is simple. If it remains true that the Commission is an essential part within the (admittedly complex) equation of EU policy-making, changes of the administration basis of this actor are likely to have broader implications. Consequently, this special issue poses three crucial questions about the recent administrative reform of the European Commission: why was such a comprehensive reform possible, what are its specific implications for the Commission as an organisation and what is the likely impact for the policy process? In short, this book puts the organisational base of EU policy-making centre stage. In the quest for answers the authors of the subsequent chapters take distinct perspectives, use various research strategies and methods, and attempt to solve diverse empirical puzzles. But all attempt to add to our understanding of this organisational base, and how to systematically study it. This book was published as a special issue of the Journal of European Public Policy.
Book Synopsis Assuring the Quality of Health Care in the European Union by : Helena Legido-Quigley
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The State in Western Europe by : Wolfgang C. Müller
Download or read book The State in Western Europe written by Wolfgang C. Müller and published by Psychology Press. This book was released on 1994 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing exclusively on the functional rather than the territorial level, this book reveals that the reshaping of the state in western Europe involves different policies across Europe and conflicting tendencies in the impact of the various reform programmes. Whilst the state may be in retreat in some respects, its activity may be increasing in others. And nowhere, not even in Britain, has its key decision-making role been seriously undermined.
Book Synopsis Diagnostic Immunohistochemistry by : David J. Dabbs
Download or read book Diagnostic Immunohistochemistry written by David J. Dabbs and published by . This book was released on 2002 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: 17 world-renowned experts offer the most current information and reliable guidance on immunohistochemical diagnoses in surgical pathology and cytopathology. Introductory chapters cover cost modeling for immunohistochemistry and immunohistochemical techniques. The following chapters utilize an organ systems and diseases approach to diagnostic tumor pathology. "A newly updated book that our laboratory staff have found very useful in our day to day work" Reviewed by: PathLab.org, Sept 2014 "...It also acts as an up-to-date bench-top reference tool. It is an easy-to-read, wellpresented text that I would recommend as a 'must have' for every pathology department". Reviewed by: Dr Gemma Petts, Imperial College London on behalf of The Bulletin of The Royal College of Pathologists, Oct 2014 Consistently organized chapters for quick access to vital information Each chapter "stands alone," providing all the information you might need on a specific topic Quick-reference boxes summarize the most important diagnostic points at the end of each text Section Colour photographs and illustrations reinforce key diagnostic points
Book Synopsis Regulatory Policy and Governance Supporting Economic Growth and Serving the Public Interest by : OECD
Download or read book Regulatory Policy and Governance Supporting Economic Growth and Serving the Public Interest written by OECD and published by OECD Publishing. This book was released on 2011-10-25 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report encourages governments to “think big” about the relevance of regulatory policy and assesses the recent efforts of OECD countries to develop and deepen regulatory policy and governance.
Book Synopsis A review of UK health research funding by : David Sir Cooksey
Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).
Book Synopsis Regulating Europe by : Giandomenico Majone
Download or read book Regulating Europe written by Giandomenico Majone and published by Routledge. This book was released on 2002-11-01 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulating Europe explains why economic and social regulation is rapidly becoming the new frontier of public policy and public administration in Europe, both at the national and EU levels. Statutory regulation, implemented by independent regulatory bodies, is replacing not only older forms of state intervention but also, to some extent, the redistributive policies of the welfare state. Thus Regulating Europe is an examiniation of the emergence of the regulatory state as the successor of the Keynesian welfare state of the past. Contributions emphasize the parallelism of policy developments at the national and European levels. Part one provides the necessary theoretical background, including a new model of demand and supply of Community regulation. The second part presents a series of case studies of particular regulatory policies and institutions in the UK, Germany, France, Spain and the EU. Part three evaluates current policy and institutional developments, pointing out how the lack of a tradition of statutory regulation in Europe affects the design of the new institutions. Special attention is devoted to the issue of the democratic accountability of expert, politically independent agencies - a problem which, contrary to widespread opinion, is as severe at the national level as it is in Brussels. It is suggested that the requirements of democratic accountability, and of subsidiarity, cannot be met by re-nationalizing European policies, much less by increasing the current level of centralization. A more promising solution is the development of regulatory networks closely integrating national and supranational regulators.
