Rockville, MD (PRWEB) July 13, 2011
The Regulatory Affairs Professionals Society (RAPS) has published a new edition of its popular text, Fundamentals of US Regulatory Affairs, regarded by many as the essential reference guide to regulatory affairs for healthcare products marketed in the US. Fundamentals of US Regulatory Affairs, Seventh Edition covers US regulatory requirements across healthcare product lines, including pharmaceuticals, medical devices, biologics and other product classifications.
The seventh edition of US Fundamentals has been updated to address current regulatory requirements from the US Food and Drug Administration (FDA) and other state and federal agencies, throughout the product lifecycle. New in this edition are chapters on Drug, Biologic and Device Regulatory Pathways; FDA Communications and Meetings; Patents and Exclusivity; and Veterinary Products.
“Advances in medical science and technology are happening faster than ever. Regulations and official guidances from FDA and other agencies overseeing the drugs, medical devices and other healthcare products we use every day are also evolving rapidly,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is absolutely critical for regulatory professionals of all experience levels to have the most current information available, and Fundamentals of US Regulatory Affairs is an indispensible tool for both learning and reference.”
The book is well-suited to professionals new to US regulatory affairs, those preparing for the US Regulatory Affairs Certification (RAC) exam or those looking for a refresher or reference on US regulatory requirements, processes and concepts. It is used as an important training tool at many prominent healthcare organizations and is a mandatory text for many university-level courses.
Fundamentals of US Regulatory Affairs, Seventh Edition is available for purchase online from the RAPS Store for $239.95 with free shipping for RAPS members or $299.95, plus shipping, for nonmembers. It can also be purchased as part of an RAC (US) exam prep package. An updated e-book version will be available soon.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org
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