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News

Global regulatory affairs reference book released

RAPS - The Regulatory Affairs Professionals Society : 02 October, 2013  (New Product)
RAPS takes healthcare regulatory compliance global with the release of a reference book that provides the fundamentals of international regulatory affairs
Global regulatory affairs reference book released


The Regulatory Affairs Professionals Society (RAPS) has published the updated, second edition of its one-of-a-kind regulatory reference book, Fundamentals of International Regulatory Affairs. This edition has been significantly expanded to cover additional topics with global implications. The book is a trusted reference for healthcare product regulatory professionals involved in multinational product development and marketing.



Since the first edition of Fundamentals of International Regulatory Affairs was published in 2010, the global regulatory environment has changed markedly. The new edition reflects significant developments in the harmonization of requirements and regulations by international bodies such as the International Conference on Harmonisation (ICH), the World Health Organization (WHO) and the relatively new International Medical Device Regulators Forum (IMDRF), which supplanted the Global Harmonization Task Force (GHTF) last year.



In addition to being a useful reference, many professionals preparing for the Global Regulatory Affairs Certification (RAC) exam cite Fundamentals as an important study tool.



The updated book is being released as regulatory professionals from around the world gather in Boston for 2013 RAPS: The Regulatory Convergence, RAPS’ signature annual event and the largest annual gathering in the world for the healthcare product regulatory profession, which concludes tomorrow.



Fundamentals of International Regulatory Affairs, Second Edition is available both in print and as an e-book for $249.95 with free shipping for RAPS members or $309.95, plus shipping, for nonmembers


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