Boston—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.
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org
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