RAPS publishes updated, ninth edition of essential European regulatory affairs reference
RAPS has just published the updated, ninth edition of Fundamentals of EU Regulatory Affairs. The book remains the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices and biologics for the European market.As the regulation of healthcare products in the EU continues to undergo significant transformation, RAPS’ Fundamentals of EU Regulatory Affairs, Ninth Edition, has been updated to cover topics including the latest information on the impact of Brexit, and the upcoming implementation of the EU’s new Medical Devices Regulation (EU MDR) and In Vitro Diagnostics Regulation (EU IVDR). The book’s chapters on medical device regulation provide an in-depth look at the changes and explain what they will mean for manufacturers, notified bodies competent authorities and other stakeholders.
Two new chapters have been added, covering the regulatory framework for advanced therapy medicinal products (ATMPs) in the EU and meetings with the European Medicines Agency (EMA) during Marketing Authorisation Application review. View the full table of contents and index, and read a sample chapter on regulatory strategy.
Updated by a group of distinguished regulatory experts, it is the only reference of its kind for regulatory professionals working in the EU market or anyone who needs know and understand rules and regulations from EMA, the European Commission or individual European national agencies.
Fundamentals of EU Regulatory Affairs, Ninth Edition, is available in both hardcover and e-book formats.