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.