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International Regulatory Harmonization Amid Globalization Of Drug Development
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Book Synopsis International Regulatory Harmonization Amid Globalization of Drug Development by : Institute of Medicine
Download or read book International Regulatory Harmonization Amid Globalization of Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2013-11-24 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis International Regulatory Harmonization Amid Globalization of Drug Development by :
Download or read book International Regulatory Harmonization Amid Globalization of Drug Development written by and published by . This book was released on 2013 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations by : Pierre-Louis Lezotre
Download or read book International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations written by Pierre-Louis Lezotre and published by Academic Press. This book was released on 2013-12-05 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Globalization Paradox by : Dani Rodrik
Download or read book The Globalization Paradox written by Dani Rodrik and published by Oxford University Press. This book was released on 2011-03-24 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Governing Science and Technology under the International Economic Order by : Shin-yi Peng
Download or read book Governing Science and Technology under the International Economic Order written by Shin-yi Peng and published by Edward Elgar Publishing. This book was released on 2018 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Dynamics of Regulatory Change by : David Vogel
Download or read book Dynamics of Regulatory Change written by David Vogel and published by Univ of California Press. This book was released on 2004-12-31 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical R&D written by and published by DIANE Publishing. This book was released on 1993 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Nanotherapeutic Strategies and New Pharmaceuticals (Part 2) by : Shahid Khan
Download or read book Nanotherapeutic Strategies and New Pharmaceuticals (Part 2) written by Shahid Khan and published by Bentham Science Publishers. This book was released on 2021-12-07 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Behind-the-Border Policies by : Joseph Francois
Download or read book Behind-the-Border Policies written by Joseph Francois and published by Cambridge University Press. This book was released on 2019-11-07 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a contemporary overview of key issues related to non-tariff trade policy measures and domestic regulation.
Book Synopsis Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by : Institute of Medicine
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Globalization and Its Discontents by : Joseph E. Stiglitz
Download or read book Globalization and Its Discontents written by Joseph E. Stiglitz and published by W. W. Norton & Company. This book was released on 2003-04-17 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: This powerful, unsettling book gives us a rare glimpse behind the closed doors of global financial institutions by the winner of the 2001 Nobel Prize in Economics. When it was first published, this national bestseller quickly became a touchstone in the globalization debate. Renowned economist and Nobel Prize winner Joseph E. Stiglitz had a ringside seat for most of the major economic events of the last decade, including stints as chairman of the Council of Economic Advisers and chief economist at the World Bank. Particularly concerned with the plight of the developing nations, he became increasingly disillusioned as he saw the International Monetary Fund and other major institutions put the interests of Wall Street and the financial community ahead of the poorer nations. Those seeking to understand why globalization has engendered the hostility of protesters in Seattle and Genoa will find the reasons here. While this book includes no simple formula on how to make globalization work, Stiglitz provides a reform agenda that will provoke debate for years to come. Rarely do we get such an insider's analysis of the major institutions of globalization as in this penetrating book. With a new foreword for this paperback edition.
Book Synopsis Pharmaceuticals, Corporate Crime and Public Health by : Graham Dukes
Download or read book Pharmaceuticals, Corporate Crime and Public Health written by Graham Dukes and published by Edward Elgar Publishing. This book was released on 2014-06-27 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Deviant Globalization by : Nils Gilman
Download or read book Deviant Globalization written by Nils Gilman and published by A&C Black. This book was released on 2011-03-24 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: >
Book Synopsis Domestic Regulation and Service Trade Liberalization by : Pierre Sauve
Download or read book Domestic Regulation and Service Trade Liberalization written by Pierre Sauve and published by World Bank Publications. This book was released on 2003-08-29 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030968224X Total Pages :273 pages Book Rating :4.3/5 (96 download)
Book Synopsis Framework for Equitable Allocation of COVID-19 Vaccine by : National Academies of Sciences, Engineering, and Medicine
Download or read book Framework for Equitable Allocation of COVID-19 Vaccine written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-11-30 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.
