International Drug Regulatory Mechanisms
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International Drug Regulatory Mechanisms
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Author : Albert I. Wertheimer
language : en
Publisher: CRC Press
Release Date : 2022-02-15
International Drug Regulatory Mechanisms written by Albert I. Wertheimer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Medical categories.
Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.
International Drug Regulatory Mechanisms
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Author : Albert I Wertheimer
language : en
Publisher: CRC Press
Release Date : 2004-08-16
International Drug Regulatory Mechanisms written by Albert I Wertheimer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-08-16 with Medical categories.
Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.
Stronger Food And Drug Regulatory Systems Abroad
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-04-09
Stronger Food And Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-09 with Medical categories.
Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.
Regulating Medicines In A Globalized World
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-04-25
Regulating Medicines In A Globalized World written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-25 with Medical categories.
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.
Drug Surveillance
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Author : Zbigniew Bańkowski
language : en
Publisher: World Health Organization
Release Date : 1994
Drug Surveillance written by Zbigniew Bańkowski and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Drug monitoring categories.
Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.
Drug Regulatory Affairs
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Author : Gaurav Agarwal
language : en
Publisher: CBS Publishers & Distributors Pvt Limited, India
Release Date : 2020-01-30
Drug Regulatory Affairs written by Gaurav Agarwal and has been published by CBS Publishers & Distributors Pvt Limited, India this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-30 with categories.
Drug Regulatory Affairs is a compilation of fundamental concepts pertaining to pharmaceutical drug regulation. Governments protect public health by strictly controlling the safety and efficacy of human medicine, veterinary medicines, medical devices, cosmetics and complementary medicines. Companies responsible for the discovery, testing, manufacture and marketing of these products must ensure sale of safe and effective products. Drug Regulatory Affairs refers to fulfilment of all aspects of drug regulations within the pharmaceutical companies from development process to finished product marketing. The book provides a sound basis on understanding of international drug regulatory guidelines controlling the quality, safety and purity of marketed drugs. The content of this book covers the syllabus of pharmacy undergraduate and postgraduate course content of drug regulatory affairs. The text focuses on delivering updated and reviewed up-to-date information on current global regulatory guidelines. The book contains information that is substantial to a comprehensive understanding of regulatory affairs and the practice in pharmaceutical industry.
International Drug Regulatory Mechanisms
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Author : Albert I. Wertheimer
language : en
Publisher: CRC Press
Release Date : 2022-02-15
International Drug Regulatory Mechanisms written by Albert I. Wertheimer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Medical categories.
Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.
The Changing Economics Of Medical Technology
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1991-02-01
The Changing Economics Of Medical Technology written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991-02-01 with Medical categories.
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.
Effective Drug Regulation
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Author : Ratanawijitrasin S
language : en
Publisher: World Health Organization
Release Date : 2002-06
Effective Drug Regulation written by Ratanawijitrasin S and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-06 with Medical categories.
Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-04-04
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-04 with Medical categories.
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.