Can I read EU Clinical Trials Regulation Overview on EtoBox?
EU Clinical Trials Regulation Overview by l'Être Humain is a document available to read on EtoBox.
What is EU Clinical Trials Regulation Overview about?
The document discusses the evolution of clinical trial authorization in the EU, highlighting the transition from Directive 2001/20/EC to Regulation (EU) No. 536/2014, which aims for harmonization and simplification of the clinical trial application process. Key changes include the establishment of a centralized EU portal for submissions, a risk-based approach to regulation, and shorter deadlines for approvals. The document also outlines challenges for national competent authorities and ethics committees in
- Author
- l'Être Humain
- Language
- EN