Posted 06 December 2017
By Zachary Brousseau
RAPS has published the updated, eighth edition of Fundamentals of EU Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the European market. The book is an essential reference for anyone who needs to know and understand rules and regulations from the European Medicines Agency, the European Commission or individual European national agencies. This new edition has been fully updated and is current through September 2017.
“Regulations governing healthcare products for the European market have been subject to major changes recently, so the new, updated edition of Fundamentals of EU Regulatory Affairs comes at an opportune time,” said RAPS Executive Director Paul Brooks. “Perhaps the biggest changes have been in the medical device area as new EU Medical Device Regulation and EU In Vitro Diagnostic Regulation were adopted this year and will go into full effect in 2020 and 2022, respectively. There are also changes ahead for medicinal product regulation. The pending European Clinical Trials Regulation could change how trials are conducted in the EU.”
View the Table of Contents and a sample chapter, Regulatory Information Resources.
RAPS also has published two sector-specific EU fundamentals books, Fundamentals of EU Medical Device Regulations and Fundamentals of EU Pharmaceutical & Biologics Regulations, which present the same content published in the parent, eighth edition, but limited to only that which is relevant to one sector or the other. This allows those who work exclusively in a particular industry to get all the information that is pertinent to them without additional content that may not be.
The list price for the full eighth edition is $395 (US)—about €335 at the current exchange rate—while RAPS members get $100 off that price. Each of the sector-specific books is available for $200 list (around €170, currently), and $150 for members. The full eighth edition is available in both print and e-book versions. The sector-specific collections are available as e-books only.
Fundamentals of EU Regulatory Affairs is useful to regulatory and legal professionals, professors, students, career-changers and government officials as a trusted reference, academic textbook and Regulatory Affairs Certification (RAC) study tool.
For more information or to order any of the fundamentals books, visit RAPS.org/fundamentals.