Fundamentals of EU Regulatory Affairs, Ninth Edition (Hardcover)

Books     Members: $295 Nonmembers: $395

Fundamentals of EU Regulatory Affairs, Ninth Edition (Hardcover)

This ninth edition of Fundamentals of EU Regulatory Affairs focuses on the significant transformation of the healthcare product regulatory landscape in the European Union (EU), including the impact of Brexit and the European Medicines Agency’s (EMA) move from London to Amsterdam. As the new regulations for medical devices and in vitro diagnostic medical devices transition into effect over the next several years, regulatory professionals will be faced with consequential challenges. The medical device chapters in this book provide an in-depth look at these changes and explain what they will mean for manufacturers, notified bodies and competent authorities.  

Two new chapters are included in this edition, covering the regulatory framework for advanced therapy medicinal products (ATMPs) in the EU and EMA meetings during review of a marketing authorisation application.

Special Offer

To purchase both the hardcover and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Note, discount is only available when purchasing both versions in the same transaction.

Sector-Specific Options
Interested in EU regulatory affairs but want to concentrate on a particular product sector? RAPS offers the option to purchase the sector-specific content of this book relating to either medical devices or pharmaceuticals individually in e-book format. 

*Both the hardcover and e-book versions of Fundamentals of EU Regulatory Affairs, Ninth Edition contain the content available in the sector-specific e-books.

Published by RAPS © 2020. Hardcover. 665 pages. ISBN: 978-1-947493-43-8.
Add to Cart Add E-book to Cart