DESCRIPTION
Expected Publication Date 4/20/2009
Edited by Stephen L. Klincewicz, Yuung Yuung Yap and Adrian Thomas with Jami L. Taylor
The international pharmacovigilance arena has become increasingly complex as emerging markets recognize the need to develop robust regulatory frameworks, while developed markets continue to grapple with the need to improve postmarketing risk management and ensure the safety of medicinal products.
Despite the recognition of the need for greater harmonization of pharmacovigilance requirements worldwide, regulatory requirements continue to diverge, resulting in significant differences in approaches to medicinal product safety.
This groundbreaking book details the pharmacovigilance systems of more than a dozen countries, and, for the first time, systematically analyzes the current state of pharmacovigilance from the perspective of practicing attorneys in every region of the world. Organized with careful attention to the unique aspects of each country’s legal system and regulatory structure, this landmark guide is an essential reference for practicing attorneys, pharmacovigilance specialists, health officials, consultants and other professionals in the postmarketing surveillance field.
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TOPIC Book
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