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 conducting clinical trials 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
The Clinical Trials Directive (2001/20/EC)
- Structure
- Contents
- Workshop session on implications
The GCP Directive (2005/28/EC)
- Structure
- Contents
- Workshop session on implications
The GMP Directive (2003/94/EC)
- Structure
- Contents
- Workshop session on implications
The Paediatric Regulations (1901/2006 and 1902/2006)
- Structure
- Contents
- Workshop session on implications
European Guidelines
- Summary of Current Guidelines with emphasis on recent additions
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