".thoroughly covers the current state of international cooperative initiatives, underlying principles, why cooperation is important, and productive objectives for the future. This book has been selected for The First Clinical Research Bookshelf Essential reading for clinical research professionals. --Journal of Clinical Research Best Practices, July 2014Reseña del editor:
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. 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; and 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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