International Drug Regulatory Mechanisms

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International Drug Regulatory Mechanisms

Albert I. Wertheimer
International Drug Regulatory Mechanisms Book PDF

Author : Albert I. Wertheimer
Publisher : CRC Press
Page : 382 pages
File Size : 40,9 Mb
Release : 2022-02-15
Category : Medical
ISBN : 9781000112030

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International Drug Regulatory Mechanisms by Albert I. Wertheimer Pdf

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

Albert I Wertheimer
International Drug Regulatory Mechanisms Book PDF

Author : Albert I Wertheimer
Publisher : CRC Press
Page : 0 pages
File Size : 51,7 Mb
Release : 2004-08-16
Category : Medical
ISBN : 0789025485

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International Drug Regulatory Mechanisms by Albert I Wertheimer Pdf

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.

Regulating Medicines in a Globalized World

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Regulating Medicines in a Globalized World Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publisher : National Academies Press
Page : 169 pages
File Size : 54,5 Mb
Release : 2020-04-25
Category : Medical
ISBN : 9780309498630

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Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Pdf

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.

International Drug Regulatory Mechanisms

Albert I. Wertheimer
International Drug Regulatory Mechanisms Book PDF

Author : Albert I. Wertheimer
Publisher : CRC Press
Page : 390 pages
File Size : 47,7 Mb
Release : 2022-02-15
Category : Medical
ISBN : 9781000156843

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International Drug Regulatory Mechanisms by Albert I. Wertheimer Pdf

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

Institute of Medicine,Committee on Technological Innovation in Medicine
The Changing Economics of Medical Technology Book PDF

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 225 pages
File Size : 42,6 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.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 118 pages
File Size : 42,9 Mb
Release : 2012-04-04
Category : Medical
ISBN : 9780309222174

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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

WHO guideline on country pharmaceutical pricing policies

Anonim
WHO guideline on country pharmaceutical pricing policies Book PDF

Author : Anonim
Publisher : World Health Organization
Page : 70 pages
File Size : 54,6 Mb
Release : 2020-09-29
Category : Business & Economics
ISBN : 9789240011878

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WHO guideline on country pharmaceutical pricing policies by Anonim Pdf

In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Book PDF

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 : 53,5 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.

Effective Drug Regulation

Ratanawijitrasin S,Eshetu Wondemagegnehu,Wondemagegnebu E,World Health Organization Staff
Effective Drug Regulation Book PDF

Author : Ratanawijitrasin S,Eshetu Wondemagegnehu,Wondemagegnebu E,World Health Organization Staff
Publisher : World Health Organization
Page : 202 pages
File Size : 41,6 Mb
Release : 2002-06
Category : Medical
ISBN : 9789241562065

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Effective Drug Regulation by Ratanawijitrasin S,Eshetu Wondemagegnehu,Wondemagegnebu E,World Health Organization Staff Pdf

Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.

Modern Methods of Clinical Investigation

Institute of Medicine,Committee on Technological Innovation in Medicine
Modern Methods of Clinical Investigation Book PDF

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 48,7 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864

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Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Regulatory Theory

Peter Drahos
Regulatory Theory Book PDF

Author : Peter Drahos
Publisher : ANU Press
Page : 820 pages
File Size : 53,9 Mb
Release : 2017-02-23
Category : Law
ISBN : 9781760461027

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Regulatory Theory by Peter Drahos Pdf

This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.

Orphans and Incentives

Institute of Medicine,Forum on Emerging Infections
Orphans and Incentives Book PDF

Author : Institute of Medicine,Forum on Emerging Infections
Publisher : National Academies Press
Page : 112 pages
File Size : 53,6 Mb
Release : 1997-10-30
Category : Medical
ISBN : 9780309174411

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Orphans and Incentives by Institute of Medicine,Forum on Emerging Infections Pdf

Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues.

Developing New Contraceptives

National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development
Developing New Contraceptives Book PDF

Author : National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development
Publisher : National Academies Press
Page : 206 pages
File Size : 50,5 Mb
Release : 1990-01-01
Category : Medical
ISBN : 9780309041478

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Developing New Contraceptives by National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development Pdf

There are numerous reasons to hasten the introduction of new and improved contraceptivesâ€"from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptivesâ€"in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United Statesâ€"covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchersâ€"everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.

Food control system assessment tool: Introduction and glossary

Food and Agriculture Organization of the United Nations
Food control system assessment tool Introduction and glossary Book PDF

Author : Food and Agriculture Organization of the United Nations
Publisher : Food & Agriculture Org.
Page : 44 pages
File Size : 47,9 Mb
Release : 2019-07-09
Category : Business & Economics
ISBN : 9789251316306

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Food control system assessment tool: Introduction and glossary by Food and Agriculture Organization of the United Nations Pdf

The main objective of the tool is to propose a harmonized, objective and consensual basis to analyse the performance of a national food control system. It is intended to be used by countries as a supporting basis for self-assessment to identify priority areas of improvement and plan sequential and coordinated activities to reach expected outcomes, and by repeating the assessment on a regular basis, countries can monitor their progresses. The Tool is based on Codex principles and Guidelines for National Food Control Systems as well as other relevant Codex guidance for food control systems, which are referenced throughout the document. Its scope is given by the dual objectives quoted in Codex guidance for these systems: protect health of consumers and ensure fair practices in the food trade. This introductory volume presents the FAO/WHO Food Control System Assessment Tool, providing background to its development and outlining its main scope and objectives. It presents a thorough review of the assessment Tool structure, breaking it down into its constitutive elements (dimensions, sub-dimensions, competencies and assessment criteria). Finally, it gives an overview of the assessment approach, from the ratings to the descriptive analysis supporting the allocation of scores. The volume also contains a glossary of useful terms and the list of Codex documents referenced in the Tool.

The Impact of Global Drug Policy on Women

Julia Buxton,Giavana Margo,Lona Burger
The Impact of Global Drug Policy on Women Book PDF

Author : Julia Buxton,Giavana Margo,Lona Burger
Publisher : Emerald Group Publishing
Page : 444 pages
File Size : 48,8 Mb
Release : 2020-11-19
Category : Social Science
ISBN : 9781839828829

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The Impact of Global Drug Policy on Women by Julia Buxton,Giavana Margo,Lona Burger Pdf

The ebook edition of this title is Open Access and freely available to read online. Examining the impact of drug criminalisation on a previously overlooked demographic, this book argues that women are disproportionately affected by a flawed policy approach.