Clinical Trial Regulatory Requirements 2020

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.

Topics

• 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