Back to Fundamentals of EU Regulatory Affairs, Seventh Edition (e-book)
Fundamentals of EU Regulatory Affairs (e-book) is the definitive guide to regulatory industry topics in the European Union—from medical devices to pharmaceuticals to biological regulations.
Order your copy of the all-new 7th Edition now to make sure you are up-to-date with the most current laws and regulations.
- Two new chapters covering:
- Falsified medicine directives
- Regenerative medicines, including stem cell technology
- All chapters on devices have been renewed since the recent European Commission’s legislations. Changes include:
- Stricter safety policies and greater protections for patients participating in clinical investigations for medical devices
- A description of how companies must demonstrate that their products have a lower risk ratio by conducting clinical investigations demonstrating safety and performance
- Updates also include a 2015 matrix listing all regulatory laws, tables, and graphics, as well as a new glossary
In recent years there have been many changes in EU medical device regulations and In Vitro Diagnostics (IVD). A new approach has been developed with recent legislative principles and requirements incorporated. The core changes deliver greater consistency and safety to patients, and bring medical device and IVD legislation up to speed with technological and scientific advancements that have taken place since the 1990s.
Fundamentals of EU Regulatory Affairs is used in undergraduate and graduate courses globally, and is relied upon by those preparing for the Regulatory Affairs Certification (EU) exam.
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Who should use this publication?
Fundamentals of EU Regulatory Affairs is designed for regulatory professionals working in the European market at all levels. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.
Check out our Fundamentals Series.
Published by RAPS © 2015. E-book. 514 pages.