CTA regulation

Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

 

 

Stephan Reynier,Project Director

Stephan Reynier is a Senior Director heading the Clinical and Vigilance Unit. He has extensive experience in projects involving the design and the implementation of a regulatory strategy for the clinical development of drugs, biologics and cells and tissue based medicinal products. 

Download the full Publication now