Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) has published the latest, updated edition of Fundamentals of EU Regulatory Affairs, the authoritative, most comprehensive reference text on regulatory requirements for healthcare and related products marketed in the European Union.
Fundamentals of EU Regulatory Affairs, Sixth Edition, includes the latest information on EU directives, regulations and guidelines on human and veterinary medicinal products, biologics, medical devices, cosmetics and food supplements, and applicable international standards and guidances.
“This text is indispensable for new and experienced regulatory professionals alike, working with EU authorities,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is also a great resource for those who may be preparing for the EU Regulatory Affairs Certification (RAC) exam.”
Several new chapters have been added to this edition, dealing with issues of growing importance to EU regulatory professionals, including reimbursement and the health technology assessments that frequently are the basis for reimbursement decisions. There also is a new chapter on crisis management and one on the special requirements for vaccines. In light of new legislation coming into effect in 2012, there also is a new chapter devoted to pharmacovigilance.
This edition of EU Fundamentals is organized into four sections covering general information, medical devices, medicinal products and other product classifications, respectively. The text is supplemented by a comparative matrix of directives, regulations and guidelines covering multiple product types, a glossary of terms and an extensive index.
Fundamentals of EU Regulatory Affairs, Sixth Edition is available for purchase online from the RAPS Store for $239.95 (US) with free shipping for RAPS members, or $299.95, plus shipping, for nonmembers.
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