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| Author | : Oliver Ziegler |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 270 |
| Release | : 2012-09-05 |
| Genre | : Political Science |
| ISBN | : 3658000546 |
Download EU Regulatory Decision Making and the Role of the United States Book in PDF, ePub and Kindle
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.
| Author | : Anu Bradford |
| Publisher | : Oxford University Press |
| Total Pages | : 368 |
| Release | : 2020-01-27 |
| Genre | : Law |
| ISBN | : 0190088605 |
Download The Brussels Effect Book in PDF, ePub and Kindle
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 | : Christoph Ossege |
| Publisher | : Springer |
| Total Pages | : 173 |
| Release | : 2016-01-06 |
| Genre | : Political Science |
| ISBN | : 1137517905 |
Download European Regulatory Agencies in EU Decision-Making Book in PDF, ePub and Kindle
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.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 169 |
| Release | : 2020-04-25 |
| Genre | : Medical |
| ISBN | : 0309498635 |
Download Regulating Medicines in a Globalized World Book in PDF, ePub and Kindle
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.
| Author | : Ariane König |
| Publisher | : |
| Total Pages | : |
| Release | : 2002 |
| Genre | : Administrative procedure |
| ISBN | : |
Download The Credibility of Expert Advice for Regulatory Decision-making in the US and EU Book in PDF, ePub and Kindle
| Author | : Scott L. Greer |
| Publisher | : World Health Organization |
| Total Pages | : 191 |
| Release | : 2017-11-20 |
| Genre | : Law |
| ISBN | : 9289050438 |
Download Civil Society and Health Book in PDF, ePub and Kindle
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 318 |
| Release | : 2011-10-25 |
| Genre | : Medical |
| ISBN | : 0309212456 |
Download Medical Devices and the Public's Health Book in PDF, ePub and Kindle
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.
| Author | : Uli Bethke |
| Publisher | : diplom.de |
| Total Pages | : 116 |
| Release | : 2006-01-20 |
| Genre | : Business & Economics |
| ISBN | : 3832492569 |
Download The Influence of Business Associations in the European Decision Making Process Book in PDF, ePub and Kindle
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 [...]
| Author | : Bernardo Delogu |
| Publisher | : Springer |
| Total Pages | : 298 |
| Release | : 2016-05-02 |
| Genre | : Political Science |
| ISBN | : 331930822X |
Download Risk Analysis and Governance in EU Policy Making and Regulation Book in PDF, ePub and Kindle
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.
| Author | : Harry Yang |
| Publisher | : CRC Press |
| Total Pages | : 177 |
| Release | : 2021-01-11 |
| Genre | : Mathematics |
| ISBN | : 0429676816 |
Download Real-World Evidence in Drug Development and Evaluation Book in PDF, ePub and Kindle
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
