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Eu Regulatory Decision Making And The Role Of The United States
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Book Synopsis EU Regulatory Decision Making and the Role of the United States by : Oliver Ziegler
Download or read book EU Regulatory Decision Making and the Role of the United States written by Oliver Ziegler and published by Springer Science & Business Media. This book was released on 2012-09-05 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oliver Ziegler raises the question of what role economic interests of the United States play in the regulatory decision making process of the European Union. Critics often assume that U. S. dominance in the world economy, fueled by a powerful business elite, has significantly affected EU regulations at the expense of environmental and consumer protection standards. The author falsifies this proposition. He shows, first, that the EU often adopts regulations against the explicit opposition of the U. S. thereby ignoring the principles of transatlantic regulatory cooperation. Second, he demonstrates that business interests in the EU are usually not homogenous and often come second to environmental and consumer concerns. In addition, the author shows the increasing role of the European Parliament in EU regulatory decison making.
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 368 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.
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 European Regulatory Agencies in EU Decision-Making by : Christoph Ossege
Download or read book European Regulatory Agencies in EU Decision-Making written by Christoph Ossege and published by Springer. This book was released on 2016-10-12 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: European Regulatory Agencies (ERAs) have become increasingly important features in EU decision-making. They aim to provide expert advice independent of political or economic considerations. This book explains whether and under what conditions ERAs comply with this scientific mandate. Expanding on rational institutionalism, Ossege provides novel insights into the behaviour of ERAs, their autonomy from 'undue' external influence, and their impact on EU policy-making. The empirical comparison of three major ERAs - the European Medicines Agency, the European Food Safety Authority, and the European Chemicals Agency - not only shows that agencies capitalise on their expertise and rule-making competences to protect their autonomy. Rather, in making strategic use of their expertise, the ERAs also guard their autonomy in areas of high political salience, though their policy influence in these areas is partially circumscribed. Based on these insights, European Regulatory Agencies in EU Decision-Making locates its subject in the wider system of European Governance and considers the perennial question of how to reconcile the need for expert advice with democratic decision-making.
Book Synopsis Understanding EU Decision-Making by : Edward Best
Download or read book Understanding EU Decision-Making written by Edward Best and published by Springer. This book was released on 2016-02-04 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents in a concise and accessible way why the EU institutional system exists in its present form, how the EU fits into the world as a system of governance, and who is involved in EU policy processes. It outlines the historical context which has shaped the EU system, gives a summary of the system's basic principles and structures, and describes its actors, procedures and instruments. The main theme is to show that EU decision-making is not just a matter of action at some higher and separate level, of ‘them and us’, but rather that it involves different forms of cooperation between European, national and regional authorities, as well as interaction between public and private actors. Numerous short case studies illustrate how people’s day-to-day activities are affected by EU decisions, and how individuals’ concerns are represented in the decision-making process. The book provides insights and examples which will be very helpful for all students of European integration. It will also be a valuable resource for European citizens wishing to understand the basic realities and rationales, as well as some of the dilemmas, behind EU policy-making.
Book Synopsis Civil Society and Health by : Scott L. Greer
Download or read book Civil Society and Health written by Scott L. Greer and published by World Health Organization. This book was released on 2017-11-20 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
Book Synopsis Better Regulation Practices across the European Union 2022 by : OECD
Download or read book Better Regulation Practices across the European Union 2022 written by OECD and published by OECD Publishing. This book was released on 2022-06-28 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. It is important that they are designed in a way that takes account of their social, environmental and business impacts and ensures they remain relevant in today’s fast-changing context. The second edition of the Better Regulation Practices across the European Union report analyses recent developments and current practices for improving the quality of laws and regulations across all 27 EU Member States and the European Union.
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 Risk Analysis and Governance in EU Policy Making and Regulation by : Bernardo Delogu
Download or read book Risk Analysis and Governance in EU Policy Making and Regulation written by Bernardo Delogu and published by Springer. This book was released on 2016-05-02 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an easy, but comprehensive and rigorous access to the main concepts, terminology, methods and procedures of risk analysis intended for all those involved in the EU policy and regulatory decision making on risks. It establishes a common ground of knowledge which enables a more informed dialogue on risks, a closer collaboration between decision makers and scientists and a better appraisal of the potential and limits of risk science. The book also brings together in an accessible way much multidisciplinary knowledge which had been dispersed over many technical documents and specialist books. The EU is in the front line of health, safety and environmental risk management. GMOs, food safety, hazardous chemicals, climate change, radiation hazards, are just a few of the popular risk issues addressed by the EU through policy and regulatory measures. The risk analysis paradigm, including risk assessment, management and communication has been at the core of the EU decision making for a long time already. EU Institutions strive for a science-based approach to risk management. Nevertheless, the dialogue and collaboration on risk issues between policy makers, stakeholders and scientists are still difficult and the potential and limits of science in support of decision making, as well as the basic concepts of risk analysis are not fully understood outside the narrow specialist circles.
Book Synopsis The Influence of Business Associations in the European Decision Making Process by : Uli Bethke
Download or read book The Influence of Business Associations in the European Decision Making Process written by Uli Bethke and published by diplom.de. This book was released on 2006-01-20 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inhaltsangabe:Abstract: Since the adoption of the Single European Act (SEA) in 1986 more and more competencies have been transferred by EU Member States to decision makers in Brussels. Beside the objective of the completion of the Single Market the scope of Community policies has widened to political co-operation, technological development, and social policy. In addition, the powers of the European Parliament were strengthened and qualified majority voting was introduced for decisions related to the completion of the internal market. Since the summits of Maastricht and Amsterdam European integration has further gained in momentum. National governments again handed over sovereignty to the European level. Jacques Delors famous quote that 80% of regulations impacting on the economic sphere were decided in Brussels today demonstrates the shift of competency. Within the last 15 years Brussels has become an important centre of power. This transference of power to the European level also has affected the behaviour of interest groups. Before 1986 it usually was sufficient to lobby the own national administration in order to influence regulations. The main function of European peak organisations at the time was on the one hand to monitor events in Brussels and report them back to their member federations on the other hand they formed a transnational network for the exchange of information. The growing power of European institutions and the strengthening of the supranational element within the European Union required interest groups to broaden their participation in the European decision making process. In addition, the technical problems regarding the realisation of the internal market, e.g. harmonisation of services, standardisation of products etc. has triggered off an enormous demand for technical input on the side of the European institutions. Since the adoption of the SEA, thus, interest groups have proliferated. New groups with new interests have emerged. Long established organisations have increased their financial and personnel resources. After Washington D.C., Brussels has become the second biggest boomtown for lobbying activities. In 1992 the Commission has estimated that approximately 3000 special interest groups with a total of 10,000 lobbyists try to influence the institutions of the European Union. The directory of interest groups lists 891 European peak organisations. Beside these Eurogroups a myriad form of actors all trying to get [...]
Book Synopsis The European Fund for Strategic Investments: The Legacy by : European Investment Bank
Download or read book The European Fund for Strategic Investments: The Legacy written by European Investment Bank and published by European Investment Bank. This book was released on 2021-01-07 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inside story of the European Fund for Strategic Investments from 2015 to 2020 told through interviews with the Managing Director, Deputy Managing Director, members of the Investment Committee and final beneficiaries across Europe. The architects of this €500 billion-plus programme, the head of the EU bank and the president of the European Commission, describe the genesis of this financial pillar of the Investment Plan for Europe. Then the people who ran one of the biggest economic stimulus programmes in history detail how they did it—and what the lessons are for policymakers responding to new crises, including the economic shock caused by the COVID-19 pandemic. The European Fund for Strategic Investments has been one of the good news stories to emerge in a decade of economic uncertainty. It has gone well beyond its highly ambitious target of €500 billion in mobilised investments. The Juncker Plan has made a strong contribution to the 14 million jobs created in the EU between 2015 and 2020. It has become a success in co-financing projects that otherwise might not have been carried through. It has also charted the path towards new ways of financing. This is not only the case in relatively conventional areas, such as infrastructure, but also in sectors like research and innovation or the contribution to climate change mitigation. This is exactly what makes EFSI so ground-breaking: responding to the needs of the market through continuous financial innovation. The principle of the European Fund for Strategic Investments is here to stay. It has paved the way for its successor, the InvestEU programme, which is to be deployed under the 2021-2027 multiannual financial framework. This publication details why the programme was such a success.
Book Synopsis Recommendation of the Council on Regulatory Policy and Governance by : OECD
Download or read book Recommendation of the Council on Regulatory Policy and Governance written by OECD and published by OECD Publishing. This book was released on 2012-11-02 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: This set of guidelines provides the measures by which governments can implement or advance regulatory reform.
Book Synopsis International Regulatory Co-operation Addressing Global Challenges by : OECD
Download or read book International Regulatory Co-operation Addressing Global Challenges written by OECD and published by OECD Publishing. This book was released on 2013-05-31 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is becoming increasingly global. This raises challenges for regulatory processes which still largely emanate from domestic jurisdictions. Governments increasingly seek to better articulate regulations across borders and to ensure greater enforcement of rules.
Book Synopsis The Role of `Experts' in International and European Decision-Making Processes by : Monika Ambrus
Download or read book The Role of `Experts' in International and European Decision-Making Processes written by Monika Ambrus and published by Cambridge University Press. This book was released on 2014-08-28 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: A broad-gauged analysis of the issues raised by experts' involvement in international and European decision-making processes.
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 2011-10-25 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 Real-World Evidence in Drug Development and Evaluation by : Harry Yang
Download or read book Real-World Evidence in Drug Development and Evaluation written by Harry Yang and published by CRC Press. This book was released on 2021-01-11 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Book Synopsis International Regulatory Harmonization Amid Globalization of Drug Development by : Institute of Medicine
Download or read book International Regulatory Harmonization Amid Globalization of Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2013-11-24 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
