Duration: 1 day
Description:
This course provides an overview of European clinical trials legislation and guidance along with some advice on practical application of the requirements.
Who it is suitable for:
The course is aimed at clinical operations staff who need an understanding of how clinical trials are conducted in the EU, for example, Project Managers, CRAs, CTAs. It is also suitable for those who need specific information regarding EU GCP requirements, for example, senior managers, auditors, pharmacovigilance staff, medical writers, etc.
Example content:
Background and History of Clinical Research Legislation in Europe
- The development of European clinical trial legislation
- European regulatory and advisory bodies
Eudralex Vol 10 - Clinical Trials
EU Clinical Trials Legislation
- The Clinical Trials Directive (2001/20/EC)
- The GCP Directive (2005/28/EC)
- The GMP Directive (2003/94/EC)
- The Paediatric Regulations (1901/2006 and 1902/2006)
European Guidelines
- Summary of Current Guidelines with emphasis on recent additions
|
