International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective - Hardcover

Lezotre, Pierre-Louis

Hardcover

ISBN 10: 0128000538 ISBN 13: 9780128000533

Publisher: Academic Press, 2014

Synopsis

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

About this title

Review:

Features the current status, driving influences and future potential of global harmonization efforts with recommendations to support next steps

From the Back Cover:

Globalization is a reality of the 21st century. The development, manufacture and distribution of medicines have been internationalized. This increased globalization has fundamentally changed the environment for regulating medicines and created unique regulatory challenges for all stakeholders. The regulatory paradigm has indeed changed from national to international and international pharmaceutical norms and standards are more important than ever before. International cooperation, convergence and harmonization of pharmaceutical regulations has become the only clear choice to meet the fundamental human right to have access to high quality, safe and effective medicines in both developed and developing countries.

In this context, many cooperative initiatives have been established at the bilateral, regional and global levels and harmonization efforts have been enhanced. All of these initiatives have taken a variety of forms, from informal cooperation to full integration of regulatory systems.

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of this 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 fulfil 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.

This book features:

• 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

About this edition

• Publisher: Academic Press
• Publication date: 2014
• ISBN 10: 0128000538
• ISBN 13: 9780128000533
• Binding: Hardcover
• Number of pages: 376