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

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9780128000533: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective

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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".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 2014

About the Author:

Dr. Pierre-Louis Lezotre specializes in global regulatory strategy, and is recognized for his passion and expertise on international cooperation, convergence, and harmonization of regulations for pharmaceutical and biotechnology products. He has worked in different cultural environments and lived in both Europe and the United States. Dr. Lezotre studied biology (University of Sciences, Saint-Etienne, France) and drug development (University of Pharmacy, Montpellier, France) from 1992 to 1998. He then received his Master in Regulatory Sciences in 1999 (University of Pharmacy, Lille, France). He also recently completed his PhD in Law with honors (Doctoral School of "Law, Politics and Management, University of Law, Lille, France). Since 1998, Dr. Lezotre has worked for several international pharmaceutical and biotechnology companies, with increasing levels of responsibility. He has served as a regional and then global regulatory leader for small molecule and biologic/biotech programs in various stages of research and development (from early discovery to life cycle management). He successfully led many global regulatory teams in supporting global registrations of major products and numerous development projects in several therapeutic areas, including dermatology, urology, neurology, and pain. He has been responsible for communications with worldwide Drug Regulatory Authorities and has also worked with external partners/ companies through co-development agreements and business development programs. Dr. Lezotre has recently been invited to teach courses on international regulation in the Regulatory Sciences programs of the University of Southern California (USC).

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Book Description Elsevier Science Publishing Co Inc, United States, 2014. Hardback. Book Condition: New. 239 x 193 mm. Language: English . Brand New Book. 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. Bookseller Inventory # AA59780128000533

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Book Description Elsevier Science Publishing Co Inc, United States, 2014. Hardback. Book Condition: New. 239 x 193 mm. Language: English . Brand New Book. 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. Bookseller Inventory # AA59780128000533

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Book Description Oxford Elsevier LTD Jan 2014, 2014. Buch. Book Condition: Neu. 241x197x27 mm. Neuware - Speech enhancement is a classical problem in signal processing, yet still largely unsolved. Two of the conventional approaches for solving this problem are linear filtering, like the classical Wiener filter, and subspace methods. These approaches have traditionally been treated as different classes of methods and have been introduced in somewhat different contexts. Linear filtering methods originate in stochastic processes, while subspace methods have largely been based on developments in numerical linear algebra and matrix approximation theory. This book bridges the gap between these two classes of methods by showing how the ideas behind subspace methods can be incorporated into traditional linear filtering. In the context of subspace methods, the enhancement problem can then be seen as a classical linear filter design problem. This means that various solutions can more easily be compared and their performance bounded and assessed in terms of noise reduction and speech distortion. The book shows how various filter designs can be obtained in this framework, including the maximum SNR, Wiener, LCMV, and MVDR filters, and how these can be applied in various contexts, like in single-channel and multichannel speech enhancement, and in both the time and frequency domains. 349 pp. Englisch. Bookseller Inventory # 9780128000533

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