Clinical Trial Regulatory Requirements
Are you up to date with the regulatory requirements for clinical research?
Do you understand the impact and new requirements of the EU Clinical Trial Regulation and delegated acts and guidelines?
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.
The interactive programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical and biotechnology companies and study sites.
Key topics to be covered include:
- The current requirements of the EU Clinical Trials Directive
- The EU Clinical Trial Regulation (536/2014)
- The impact of Brexit
- Clinical trial authorisations
- Complexities for running paediatric trials
- Requirements for managing investigational medicinal products
- Legal aspects of clinical trials
- Requirements of pharmacovigilance
- ICH GCP R2 guideline requirements
- Regulatory inspections