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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: R. McGill
Publisher: Springer
ISBN: 0230511988
Category : Business & Economics
Languages : en
Pages : 250
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
Get Book Here
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: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111
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Book Description
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.
Author: Jeffrey Gibbs
Publisher:
ISBN: 9781935065890
Category :
Languages : en
Pages :
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Book Description
Author: Dr Norman Mugarura
Publisher: Ashgate Publishing, Ltd.
ISBN: 1409456617
Category : Law
Languages : en
Pages : 532
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Book Description
Examining the challenges of using the global anti-money laundering (AML) framework in an uneven global regulatory landscape, this book discusses the difficulties of relating de-regulation, liberalization and conflict of laws to the dynamics of the market economy and demonstrates how the global environment engenders money laundering. It suggests that corruption, general systemic failure and lack of infrastructural capacity in some developing economies are hampering the implementation of laws and regulations. Suggesting that these challenges can be overcome by designing AML regimes more suited to developing economies within the prevailing global climate, the book questions the assumption that that global regimes will be applicable and emphasises the need for more representation of developing economies on the relevant committees. This book is the first of its kind to present the perspective of developing economies and their involvement in AML regimes and should be of interest to those involved in business and commercial law as well as comparative law.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399
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Book Description
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Author: Roselyn Hsueh Romano
Publisher: Cornell University Press
ISBN: 080146286X
Category : Political Science
Languages : en
Pages : 321
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Book Description
Today's China is governed by a new economic model that marks a radical break from the Mao and Deng eras; it departs fundamentally from both the East Asian developmental state and its own Communist past. It has not, however, adopted a liberal economic model. China has retained elements of statist control even though it has liberalized foreign direct investment more than any other developing country in recent years. This mode of global economic integration reveals much about China’s state capacity and development strategy, which is based on retaining government control over critical sectors while meeting commitments made to the World Trade Organization. In China's Regulatory State, Roselyn Hsueh demonstrates that China only appears to be a more liberal state; even as it introduces competition and devolves economic decisionmaking, the state has selectively imposed new regulations at the sectoral level, asserting and even tightening control over industry and market development, to achieve state goals. By investigating in depth how China implemented its economic policies between 1978 and 2010, Hsueh gives the most complete picture yet of China's regulatory state, particularly as it has shaped the telecommunications and textiles industries. Hsueh contends that a logic of strategic value explains how the state, with its different levels of authority and maze of bureaucracies, interacts with new economic stakeholders to enhance its control in certain economic sectors while relinquishing control in others. Sectoral characteristics determine policy specifics although the organization of institutions and boom-bust cycles influence how the state reformulates old rules and creates new ones to maximize benefits and minimize costs after an initial phase of liberalization. This pathbreaking analysis of state goals, government-business relations, and methods of governance across industries in China also considers Japan’s, South Korea’s, and Taiwan’s manifestly different approaches to globalization.
Author: United States. Congress. House. Committee on Small Business. Subcommittee on Investigations, Oversight, and Regulations
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 88
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Book Description
Author: Imad A Moosa
Publisher: World Scientific
ISBN: 981310953X
Category : Law
Languages : en
Pages : 423
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Book Description
The book deals with contemporary issues in financial regulation, given the post-crisis regulatory landscape. The major idea put forward is that rampant corruption and fraud in the financial sector provide the main justification for financial regulation. Specific issues that are dealt with include the proposition that the Efficient Market Hypothesis was both a cause and a casualty of the global financial crisis. The book also examines the regulation of remuneration in the financial sector, credit rating agencies and shadow banking. Also considered is financial reform in Iceland and the proposal to move away from fractional reserve banking to a system of sovereign money. A macroeconomic/regulatory issue that is also considered is quantitative easing and the resulting environment of ultra-low interest rates.
Author: André Pereira da Fonseca,
Publisher: Kluwer Law International B.V.
ISBN: 9403506857
Category : Law
Languages : en
Pages : 660
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Book Description
In the process of resolving disputes, it is not uncommon for parties to justify actions otherwise in breach of their obligations by invoking the need to protect some aspect of the elusive concept of public order. Until this thoroughly researched book, the criteria and factors against which international dispute bodies assess such claims have remained unclear. Now, by providing an in-depth comparative analysis of relevant jurisprudence under four distinct international dispute resolution systems – trade, investment, human rights and international commercial arbitration – the author of this invaluable book identifies common core benchmarks for the application of the public order exception. To achieve the broadest possible scope for her analysis, the author examines the public order exception’s function, role and application within the following international dispute resolution systems: relevant World Trade Organization (WTO) agreements as enforced by the organization’s Dispute Settlement Body and Appellate Body; international investment agreements as enforced by competent Arbitral Tribunals and Annulment Committees under the International Center for Settlement of Investment Disputes; provisions under the Inter-American Convention of Human Rights and the European Convention of Human Rights as enforced by the Inter-American Court of Human Rights and the European Court of Human Rights, respectively; and the New York Convention as enforced by national tribunals across the world. Controversies, tensions and pitfalls inherent in invoking the public order exception are elucidated, along with clear guidelines on how arguments may be crafted in order to enhance prospects of success. Throughout, tables and graphs systematize key aspects of the relevant jurisprudence under each of the dispute resolution systems analysed. As an immediate practical resource for lawyers on any side of a dispute who wish to invoke or strengthen a public order exception claim, the book’s systematic analysis will be welcomed by lawyers active in WTO disputes, international investment arbitration, human rights law or enforcement of foreign arbitral awards. Academics and policymakers will find a signal contribution to the ongoing debate on the existence, legal basis, content and functions of the transnational public order.
