The New Global Regulatory Landscape

The New Global Regulatory Landscape
Author: R. McGill
Publisher: Springer
Total Pages: 250
Release: 2005-07-22
Genre: Business & Economics
ISBN: 0230511988

The New Global Regulatory Landscape provides a benchmark tool for financial intermediaries and Institutional Investors. Covering 24 international regulations across the UK, Europe, Asia/Pacific and the USA, the authors provide practical compliance tips for financial intermediaries and guidance on best practice for investors. The book highlights eight areas of critical overlap where regulatory requirements conflict and give rise to potential risk and liability. The authors use the historical perspective of some regulations to paint a picture of the future convergence of international regulation on data protection, corporate governance and tax.

The New Global Rulers

The New Global Rulers
Author: Tim Büthe
Publisher: Princeton University Press
Total Pages: 320
Release: 2011-02-28
Genre: Political Science
ISBN: 1400838797

Global private regulations—who wins, who loses, and why Over the past two decades, governments have delegated extensive regulatory authority to international private-sector organizations. This internationalization and privatization of rule making has been motivated not only by the economic benefits of common rules for global markets, but also by the realization that government regulators often lack the expertise and resources to deal with increasingly complex and urgent regulatory tasks. The New Global Rulers examines who writes the rules in international private organizations, as well as who wins, who loses--and why. Tim Büthe and Walter Mattli examine three powerful global private regulators: the International Accounting Standards Board, which develops financial reporting rules used by corporations in more than a hundred countries; and the International Organization for Standardization and the International Electrotechnical Commission, which account for 85 percent of all international product standards. Büthe and Mattli offer both a new framework for understanding global private regulation and detailed empirical analyses of such regulation based on multi-country, multi-industry business surveys. They find that global rule making by technical experts is highly political, and that even though rule making has shifted to the international level, domestic institutions remain crucial. Influence in this form of global private governance is not a function of the economic power of states, but of the ability of domestic standard-setters to provide timely information and speak with a single voice. Büthe and Mattli show how domestic institutions' abilities differ, particularly between the two main standardization players, the United States and Europe.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 141
Release: 2010-10-04
Genre: Medical
ISBN: 0309162904

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.

Neuroscience Trials of the Future

Neuroscience Trials of the Future
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 111
Release: 2016-11-07
Genre: Medical
ISBN: 0309442583

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 169
Release: 2020-04-25
Genre: Medical
ISBN: 0309498635

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.

Global Regulatory Standards in Environmental and Health Disputes

Global Regulatory Standards in Environmental and Health Disputes
Author: Caroline E. Foster
Publisher: Oxford University Press
Total Pages: 417
Release: 2021
Genre: Law
ISBN: 0198810555

Global regulatory standards are emerging from the environmental and health jurisprudence of the International Court of Justice, the World Trade Organization, under the United Nations Convention on the Law of the Sea, and investor-state dispute settlement. Most prominent are the three standards of regulatory coherence, due regard for the rights of others, and due diligence in the prevention of harm. These global regulatory standards are a phenomenon of our times, representing a new contribution to the ordering of the relationship between domestic and international law, and a revised conception of sovereignty in an increasingly pluralistic global legal era. However, the legitimacy of the resulting 'standards-enriched' international law remains open to question. International courts and tribunals should not be the only fora in which these standards are elaborated, and many challenges and opportunities lie ahead in the ongoing development of global regulatory standards. Debate over whether regulatory coherence should go beyond reasonableness and rationality requirements and require proportionality stricto sensu in the relationship between regulatory measures and their objectives is central. Due regard, the most novel of the emerging standards, may help protect international law's legitimacy claims in the interim. Meanwhile, all actors should attend to the integration rather than the fragmentation of international law, and to changes in the status of private actors.

Doing Business 2020

Doing Business 2020
Author: World Bank
Publisher: World Bank Publications
Total Pages: 254
Release: 2019-11-21
Genre: Business & Economics
ISBN: 1464814414

Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.

Regulatory Aspects of Artificial Intelligence on Blockchain

Regulatory Aspects of Artificial Intelligence on Blockchain
Author: Tehrani, Pardis Moslemzadeh
Publisher: IGI Global
Total Pages: 273
Release: 2021-09-24
Genre: Computers
ISBN: 1799879291

The convergence of Artificial Intelligence (AI) in blockchain creates one of the world’s most reliable technology-enabled decision-making systems that is virtually tamper-proof and provides solid insights and decisions. The integration of AI and Blockchain affects many aspects from food supply chain logistics and healthcare record sharing to media royalties and financial security. It is imperative that regulatory standards are emphasized in order to support positive outcomes from the integration of AI in blockchain technology. Regulatory Aspects of Artificial Intelligence on Blockchain provides relevant legal and security frameworks and the latest empirical research findings in blockchain and AI. Through the latest research and standards, the book identifies and offers solutions for overcoming legal consequences that pertain to the application of AI into the blockchain system, especially concerning the usage of smart contracts. The chapters, while investigating the legal and security issues associated with these applications, also include topics such as smart contacts, network vulnerability, cryptocurrency, machine learning, and more. This book is essential for technologists, security analysts, legal specialists, privacy and data security practitioners, IT consultants, standardization professionals, researchers, academicians, and students interested in blockchain and AI from a legal and security viewpoint.