International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations PDF Author: Pierre-Louis Lezotre
Publisher: Academic Press
ISBN: 0128005696
Category : Medical
Languages : en
Pages : 376

Book Description
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

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations PDF Author: Pierre-Louis Lezotre
Publisher: Academic Press
ISBN: 0128005696
Category : Medical
Languages : en
Pages : 376

Book Description
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

International Regulatory Harmonization Amid Globalization of Drug Development

International Regulatory Harmonization Amid Globalization of Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309284791
Category : Medical
Languages : en
Pages : 129

Book Description
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.

The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation PDF Author: Sabrina Röttger-Wirtz
Publisher: Bloomsbury Publishing
ISBN: 1509943013
Category : Law
Languages : en
Pages : 288

Book Description
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 Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Rethinking Participation in Global Governance

Rethinking Participation in Global Governance PDF Author: Joost Pauwelyn
Publisher: Oxford University Press
ISBN: 0198852568
Category : Law
Languages : en
Pages : 545

Book Description
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.

Ethics in Nanotechnology

Ethics in Nanotechnology PDF Author: Marcel Van de Voorde
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110701979
Category : Technology & Engineering
Languages : en
Pages : 266

Book Description
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 scientist, as well as all other industry professionals and researchers who interact with emerging social and philosophical ethical issues on routine bases. It is especially for deep learners who are enthusiastic to apprehend the challenges related to nanotechnology and ethics in philosophical and social education. This book presents an overview of new and emerging nanotechnologies and their societal and ethical implications. It is meant for students, academics, scientists, engineers, policy makers, ethicist, philosophers and all stakeholders involved in the development and use of nanotechnology.

Drugs Law and Legal Practice in Southeast Asia

Drugs Law and Legal Practice in Southeast Asia PDF Author: Tim Lindsey
Publisher: Bloomsbury Publishing
ISBN: 1782258337
Category : Law
Languages : en
Pages : 408

Book Description
Drugs Law and Legal Practice in Southeast Asia investigates criminal law and practice relevant to drugs regulation in three Southeast Asian jurisdictions: Indonesia, Singapore and Vietnam. These jurisdictions represent a spectrum of approaches to drug regulation in Southeast Asia, highlighting differences in practice between civil and common law countries, and between liberal and authoritarian states. This book offers the first major English language empirical investigation and comparative analysis of regulation, jurisprudence, court procedure, and practices relating to drugs law enforcement in these three states.

Dosage Form Design Parameters

Dosage Form Design Parameters PDF Author:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 810

Book Description
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 and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Drug Safety in Developing Countries

Drug Safety in Developing Countries PDF Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Business & Economics
Languages : en
Pages : 656

Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Pharmaceuticals in the European Union

Pharmaceuticals in the European Union PDF Author: Giuditta Savonitto
Publisher: Cambridge Scholars Publishing
ISBN: 1527533603
Category : Political Science
Languages : en
Pages : 189

Book Description
This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here. In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.

Pharmacovigilance

Pharmacovigilance PDF Author: I. Ralph Edwards
Publisher: Springer
ISBN: 3319404008
Category : Medical
Languages : en
Pages : 205

Book Description
Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.