Clinical Trial Regulatory Requirements 2020 is a conference dedicated to key regulatory & guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulations.
Clinical Trial Regulatory Requirements 2020 covers topics such as:
- Key areas of the EU Clinical Trial Directive
- Current framework of clinical trial regulations in Europe
- The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive
- Brief overview of the GCP Directive
- Clinical Trial Application (CTA) and how this will change with the new Clinical Trial Regulation
- Clinical trial regulatory authorisation and amendments
- Running clinical trials in children: the paediatric plan and ethical considerations
- Ethics Committee (EC) submissions and approval
- Investigational medicinal product
- Brief overview of legal aspects of clinical trials
- Brief overview of other recent EU and FDA developments in clinical trial requirements including:
- Pharmacovigilance and adverse event reporting
- Brief considerations for preparing for regulatory inspection