International Regulatory Harmonization Amid Globalization Of Drug Development

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 129 pages
File Size : 51,6 Mb
Release : 2013-11-24
Category : Medical
ISBN : 9780309284790

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International Regulatory Harmonization Amid Globalization of Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 41,7 Mb
Release : 2013
Category : Electronic
ISBN : OCLC:971092227

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International Regulatory Harmonization Amid Globalization of Drug Development by Anonim Pdf

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 225 pages
File Size : 45,6 Mb
Release : 1991-02-01
Category : Medical
ISBN : 9780309044912

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The Changing Economics of Medical Technology by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Author : David Vogel,Robert A. Kagan
Publisher : Univ of California Press
Page : 384 pages
File Size : 43,6 Mb
Release : 2004-12-31
Category : Business & Economics
ISBN : 0520245350

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Dynamics of Regulatory Change by David Vogel,Robert A. Kagan Pdf

Critics of globalization claim that economic liberalization leads to a lowering of regulatory standards. As capital and corporations move more freely across national boundaries, a race to the bottom results as governments are forced to weaken labor and environmental standards to retain current contracts or attract new business. The essays in this volume argue that, on the contrary, under certain circumstances global economic integration can actually lead to the strengthening of consumer and environmental standards. This volume extends the argument of David Vogel’s book Trading Up, which discussed environmental standards, by focusing on the impact of globalization on labor rights, women’s rights and capital market regulations.

Author : Shin-yi Peng,Han-Wei Liu,Ching-Fu Lin
Publisher : Edward Elgar Publishing
Page : 400 pages
File Size : 43,5 Mb
Release : 2018
Category : Electronic
ISBN : 9781788115568

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Governing Science and Technology under the International Economic Order by Shin-yi Peng,Han-Wei Liu,Ching-Fu Lin Pdf

Against the backdrop of the recent trend towards megaregional trade initiatives, this book addresses the most topical issues that lie at the intersection of law and technology. By assessing international law and the political economy, the contributing authors offer an enhanced understanding of the challenges of diverging regulatory approaches to innovation.

Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publisher : National Academies Press
Page : 366 pages
File Size : 41,7 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Pdf

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

Author : Shahid Khan
Publisher : Bentham Science Publishers
Page : 285 pages
File Size : 55,6 Mb
Release : 2021-12-07
Category : Medical
ISBN : 9789815036732

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Nanotherapeutic Strategies and New Pharmaceuticals (Part 2) by Shahid Khan Pdf

Advances in technology have enabled medicinal chemists to discover and formulate several highly specific, biocompatible, and non-toxic therapeutic agents for clinical applications. Nanotechnology has achieved significant progress in the last few decades and is crucial in every field of science and technology. Nanotechnology-based pharmaceuticals offer multifaceted and alternative methodologies in comparison to the limitations of many conventional clinical therapies. Expertise in designing and developing nanoformulations has helped in targeted drug delivery. Recently, the use of innovative therapeutic agents, particularly in nanomedicine, has accounted for a significant portion of the global pharmaceutical market and is predicted to continue to grow rapidly in the near future. Nanotherapeutic Strategies and New Pharmaceuticals is an accessible multi-part reference which informs the reader about several new techniques based on nanotechnology. The chapters explain relevant topics in detail. The book is designed to encourage and help undergraduate, graduate and post-graduate students in the field of nanotherapeutics, pharmaceuticals and bio-organic chemistry through the use of didactic language and simple illustrations. Part 2 of this book covers the potential of nanotherapeutics and natural therapies for treating neurological diseases, targeting ion channels, signal transduction therapy, gene therapy of single gene mutation diseases and for nanoformulations for special purposes such as wound healing and stimuli-responsive drug delivery. The book also features a chapter that summarizes the types of nanoparticles tailored for specific molecular targets that mediate different diseases. The book set serves as a textbook for students in pharmacology and medical biochemistry, as well as a quick reference for researchers on bio-organic chemistry, as well as general readers interested in nanomedicine.

Author : Joseph Francois,Bernard Hoekman
Publisher : Cambridge University Press
Page : 385 pages
File Size : 49,7 Mb
Release : 2019-11-07
Category : Business & Economics
ISBN : 9781108485531

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Behind-the-Border Policies by Joseph Francois,Bernard Hoekman Pdf

Provides a contemporary overview of key issues related to non-tariff trade policy measures and domestic regulation.

Author : Graham Dukes,John Braithwaite,J P Moloney
Publisher : Edward Elgar Publishing
Page : 424 pages
File Size : 50,6 Mb
Release : 2014-06-27
Category : Business & Economics
ISBN : 9781783471102

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Pharmaceuticals, Corporate Crime and Public Health by Graham Dukes,John Braithwaite,J P Moloney Pdf

The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr

Author : Anonim
Publisher : DIANE Publishing
Page : 380 pages
File Size : 52,7 Mb
Release : 1993
Category : Drugs
ISBN : 0788104683

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Pharmaceutical R&D by Anonim Pdf

Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.

Author : Dani Rodrik
Publisher : Oxford University Press
Page : 369 pages
File Size : 41,7 Mb
Release : 2011-03-24
Category : Business & Economics
ISBN : 9780199603336

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The Globalization Paradox by Dani Rodrik Pdf

For a century, economists have driven forward the cause of globalization in financial institutions, labour markets, and trade. Yet there have been consistent warning signs that a global economy and free trade might not always be advantageous. Where are the pressure points? What could be done about them?Dani Rodrik examines the back-story from its seventeenth-century origins through the milestones of the gold standard, the Bretton Woods Agreement, and the Washington Consensus, to the present day. Although economic globalization has enabled unprecedented levels of prosperity in advanced countries and has been a boon to hundreds of millions of poor workers in China and elsewhere in Asia, it is a concept that rests on shaky pillars, he contends. Its long-term sustainability is not a given.The heart of Rodrik>'s argument is a fundamental 'trilemma': that we cannot simultaneously pursue democracy, national self-determination, and economic globalization. Give too much power to governments, and you have protectionism. Give markets too much freedom, and you have an unstable world economy with little social and political support from those it is supposed to help. Rodrik argues for smart globalization, not maximum globalization.

Author : Pierre Sauve,Aaditya Mattoo
Publisher : World Bank Publications
Page : 244 pages
File Size : 47,5 Mb
Release : 2003-08-29
Category : Political Science
ISBN : 9780821383438

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Domestic Regulation and Service Trade Liberalization by Pierre Sauve,Aaditya Mattoo Pdf

Trade in services, far more than trade in goods, is affected by a variety of domestic regulations, ranging from qualification and licensing requirements in professional services to pro-competitive regulation in telecommunications services. Experience shows that the quality of regulation strongly influences the consequences of trade liberalization. WTO members have agreed that a central task in the ongoing services negotiations will be to develop a set of rules to ensure that domestic regulations support rather than impede trade liberalization. Since these rules are bound to have a profound impact on the evolution of policy, particularly in developing countries, it is important that they be conducive to economically rational policy-making. This book addresses two central questions: What impact can international trade rules on services have on the exercise of domestic regulatory sovereignty? And how can services negotiations be harnessed to promote and consolidate domestic policy reform across highly diverse sectors? The book, with contributions from several of the world's leading experts in the field, explores a range of rule-making challenges arising at this policy interface, in areas such as transparency, standards and the adoption of a necessity test for services trade. Contributions also provide an in-depth look at these issues in the key areas of accountancy, energy, finance, health, telecommunications and transportation services.

Author : UNCTAD
Publisher : United Nations
Page : 160 pages
File Size : 40,5 Mb
Release : 2019-01-16
Category : Political Science
ISBN : 9789210473224

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Trade and Development Report 2018 by UNCTAD Pdf

This flagship publication examines different aspects of the nature and role of international trade in the era of hyperglobalization and considers related policy challenges that will need to be addressed if trade is to contribute to a more stable and inclusive global economic order. Research provides authoritative data and analysis on trade, investment, finance and technology. UNCTAD offers solutions to the major challenges facing developing countries, particularly the poorest and most vulnerable nations. Beyond tailored analysis and policy recommendations, UNCTAD research also generates global standards that govern responsible sovereign lending and borrowing, investment, entrepreneurship, competition and consumer protection and trade rules.

Author : Unesco
Publisher : UNESCO
Page : 392 pages
File Size : 40,8 Mb
Release : 2010-01-01
Category : Technology & Engineering
ISBN : 9789231041563

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Engineering by Unesco Pdf

This report reviews engineering's importance to human, economic, social and cultural development and in addressing the UN Millennium Development Goals. Engineering tends to be viewed as a national issue, but engineering knowledge, companies, conferences and journals, all demonstrate that it is as international as science. The report reviews the role of engineering in development, and covers issues including poverty reduction, sustainable development, climate change mitigation and adaptation. It presents the various fields of engineering around the world and is intended to identify issues and challenges facing engineering, promote better understanding of engineering and its role, and highlight ways of making engineering more attractive to young people, especially women.--Publisher's description.

Author : Nils Gilman,Jesse Goldhammer,Steven Weber
Publisher : A&C Black
Page : 311 pages
File Size : 54,7 Mb
Release : 2011-03-24
Category : Political Science
ISBN : 9781441178107

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Deviant Globalization by Nils Gilman,Jesse Goldhammer,Steven Weber Pdf

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