Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training.
This must-attend course provides a review of recent changes to relevant guidance and legislation and will look at how these developments have been implemented and are likely to be implemented. Topics covered will include the EU Clinical Trials Regulation and associated documents and an update on ICH GCP R3
This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors.
Benefits of attending
- Be updated on ICH GCP R3
- Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA considerations
- Review the requirements of clinical trail essential documentation
- Identify common audit and inspection findings to help prepare for inspection
- Understand the EU Clinical Trial Regulation requirements
- Clarify requirements for data integrity and governance
- Explore technology advances in clinical trials
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Brief review of regulatory authority inspection findingsEMA, MHRA and FDA findings
New ICH GCP E6 R3 draft guideline
Other ICH updates
Data integrity governance
EU Clinical Trial Regulation (536/2014) update
Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3
Awareness update from EU and FDA
Digitalisation and technology advances and GCP
