Regulatory Affairs for Clinical Trials

This 2-day practical course will take delegates through the essential regulatory requirements for clinical research in Europe and wll also include key US requirements which impact on trials in Europe. 

The most important areas of regulations and guidelines controlling clinical trials will be covered including: understanding the importance of the EU Clinical Trial Directive; clinical trial authorisations; the increasingly important requirements for running trials in children; requirements for managing investigational medicinal product; legal aspects of clinical trials; pharmacovigilance; data management, GCP requirements; regulatory inspection and more. Topics will also include an update on the latest CT Directive guidelines and other EU Clinical Trial developments.

• Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
• Ensure compliance in regulatory requirements for investigational medicinal products, pharmacovigilance, and Clinical Trial Data Management including EDC and e-source
• Explore recent developments in clinical trial regulations including FDA requirements
• Achieve successful regulatory inspections