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Author: Oliver Ziegler
Publisher: Springer Science & Business Media
ISBN: 3658000546
Category : Political Science
Languages : en
Pages : 270
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Book Description
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: Oliver Ziegler
Publisher: Springer Science & Business Media
ISBN: 3658000546
Category : Political Science
Languages : en
Pages : 270
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Book Description
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: Harry Yang
Publisher: CRC Press
ISBN: 0429676824
Category : Mathematics
Languages : en
Pages : 191
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Book Description
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
Author: OECD
Publisher: OECD Publishing
ISBN: 9264311734
Category :
Languages : en
Pages : 199
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Book Description
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 ...
Author: Anu Bradford
Publisher: Oxford University Press
ISBN: 0190088605
Category : Law
Languages : en
Pages : 425
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Book Description
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: 0309498635
Category : Medical
Languages : en
Pages : 169
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Book Description
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: Edward Best
Publisher: Springer
ISBN: 3319223747
Category : Political Science
Languages : en
Pages : 155
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Book Description
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.
Author: Pascal Fontaine
Publisher:
ISBN: 9789279715624
Category :
Languages : en
Pages : 106
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Book Description
What purpose does the EU serve? Why and how was it set up? How does it work? What has it already achieved for its citizens, and what new challenges does it face today? In a globalised world, can the EU compete successfully with other major economies while maintaining its social standards? How can immigration be managed? What will Europe’s role be on the world stage in the years ahead? Where will the EU’s boundaries be drawn? And what future is there for the euro? These are just some of the questions explored by EU expert Pascal Fontaine in this 2017 edition of his popular booklet Europe in 12 lessons. Pascal Fontaine is a former assistant to Jean Monnet and former professor at the Institut d’Études Politiques, Paris.
Author: United States. Congress. House. Committee on Ways and Means. Subcommittee on Trade
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 232
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Book Description
Author: M. Smith
Publisher: Springer
ISBN: 0230337767
Category : Political Science
Languages : en
Pages : 195
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Book Description
During the first decade of the twenty-first century, the United States increasingly has relaxed its regulatory posture in the face of critical challenges to public health and the environment. This is true for regulation of recycling of end-of-life products, including autos and electronic components; potentially hazardous chemicals; and health claims on food labels. Coincidentally, the European Union has gravitated toward more restrictive regulation in these very same areas. How might we explain these diverging regulatory trajectories of the world s two largest market economies in an era of rising public awareness of dangers to the public and the planet? The explanation derives not from cultural differences in willingness to tolerate risk, but rather from distinctive regulatory tradeoffs - between environment and competitiveness in the United States and environment, competitiveness, and integration in the EU.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264116575
Category :
Languages : en
Pages : 155
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Book Description
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.
