International Cooperation Convergence and Harmonization of Pharmaceutical Regulations

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  • Publisher : Academic Press
  • Release : 05 December 2013
  • ISBN : 9780128005699
  • Page : 376 pages
  • Rating : 4.5/5 from 103 voters

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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

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International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations
  • Author : Pierre-Louis Lezotre
  • Publisher : Academic Press
  • Release Date : 2013-12-05
  • ISBN : 9780128005699
GET THIS BOOKInternational Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

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

International Regulatory Harmonization Amid Globalization of Drug Development

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
  • Release Date : 2013-11-24
  • ISBN : 9780309284790
GET THIS BOOKInternational Regulatory Harmonization Amid Globalization of Drug Development

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

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
  • 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
  • Release Date : 2020-04-25
  • ISBN : 9780309498630
GET THIS BOOKRegulating Medicines in a Globalized World

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

INTERNATIONAL COOPERATION FOR REGISTRATION OF MEDICINES

INTERNATIONAL COOPERATION FOR REGISTRATION OF MEDICINES
  • Author : ICRIER HEALTH POLICY INITIATIVE.
  • Publisher : Unknown
  • Release Date : 2018
  • ISBN : 9332704252
GET THIS BOOKINTERNATIONAL COOPERATION FOR REGISTRATION OF MEDICINES

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade
  • Author : World Intellectual Property Organization
  • Publisher : WIPO
  • Release Date : 2013
  • ISBN : 9789280523089
GET THIS BOOKPromoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation
  • Author : Sabrina Röttger-Wirtz
  • Publisher : Bloomsbury Publishing
  • Release Date : 2021-08-26
  • ISBN : 9781509943012
GET THIS BOOKThe Interplay of Global Standards and EU Pharmaceutical Regulation

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European

Global Business Regulation

Global Business Regulation
  • Author : John Braithwaite,Peter Drahos
  • Publisher : Cambridge University Press
  • Release Date : 2000-02-13
  • ISBN : 9781107717503
GET THIS BOOKGlobal Business Regulation

Across an amazing sweep of the critical areas of business regulation - from contract, intellectual property and corporations law, to trade, telecommunications, labour standards, drugs, food, transport and environment - this book confronts the question of how the regulation of business has shifted from national to global institutions. Based on interviews with 500 international leaders in business and government, this book examines the role played by global institutions such as the WTO, the OECD, IMF, Moody's and the World Bank, as

WHO guideline on country pharmaceutical pricing policies

WHO guideline on country pharmaceutical pricing policies
  • Author : Anonim
  • Publisher : World Health Organization
  • Release Date : 2020-09-29
  • ISBN : 9789240011878
GET THIS BOOKWHO guideline on country pharmaceutical pricing policies

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

Price Setting and Price Regulation in Health Care

Price Setting and Price Regulation in Health Care
  • Author : OECD,World Health Organization,Barber Sarah L,Lorenzoni Luca,Ong Paul
  • Publisher : OECD Publishing
  • Release Date : 2019-06-26
  • ISBN : 9789264508866
GET THIS BOOKPrice Setting and Price Regulation in Health Care

The objectives of this study are to describe experiences in price setting and how pricing has been used to attain better coverage, quality, financial protection, and health outcomes. It builds on newly commissioned case studies and lessons learned in calculating prices, negotiating with providers, and monitoring changes. Recognising that no single model is applicable to all settings, the study aimed to generate best practices and identify areas for future research, particularly in low- and middle-income settings. The report and the

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices
  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2017-05-09
  • ISBN : 9241512350
GET THIS BOOKWHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation.

Rethinking Participation in Global Governance

Rethinking Participation in Global Governance
  • Author : Joost Pauwelyn,Professor of International Law Joost Pauwelyn,Martino Maggetti,Professor and Chair for International Relations Tim Büthe,Tim Büthe,Adjunct Assistant Professor Ayelet Berman,Ayelet Berman
  • Publisher : Oxford University Press
  • Release Date : 2022-03-31
  • ISBN : 9780198852568
GET THIS BOOKRethinking Participation in Global Governance

This addition to the Law and Global Governance Series examines participation of stakeholders in treaty-based intergovernmental organizations. Readers are offered a comprehensive account of what has been done to facilitate the participation of previously neglected stakeholders.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
  • Author : Divya Vohora,Gursharan Singh
  • Publisher : Academic Press
  • Release Date : 2017-11-14
  • ISBN : 9780128020982
GET THIS BOOKPharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these

Ethics in Nanotechnology

Ethics in Nanotechnology
  • Author : Marcel Van de Voorde,Gunjan Jeswani
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2021-09-06
  • ISBN : 9783110701975
GET THIS BOOKEthics in Nanotechnology

With nanotechnology being a relatively new field, the questions regarding safety and ethics are steadily increasing with the development of the research. This book aims to give an overview on the ethics associated with employing nanoscience for products with everyday applications. The risks as well as the regulations are discussed, and an outlook for the future of nanoscience on a manufacturer’s scale and for the society is provided. Ethics in nanotechnology is a valuable resource for, philosophers, academicians and

Dosage Form Design Parameters

Dosage Form Design Parameters
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-25
  • ISBN : 9780128144220
GET THIS BOOKDosage Form Design Parameters

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Publisher : National Academies Press
  • Release Date : 2010-10-04
  • ISBN : 0309162904
GET THIS BOOKPublic Health Effectiveness of the FDA 510(k) Clearance Process

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.