EFGCP Summer Workshop
Proactive inspection readiness - anticipating future regulatory changes
The Workshop will be held virtually and is postponed to Q3 2023. The date will follow as soon as possible.
interactive, practical workshop will feature a range of speakers on topics
including Investigational Medicinal Product Management, consent, and a shared
workshop on decentralised clinical trials.
Working in groups, we’ll look at different aspects of decentralised trials and practical considerations from those ‘in the know’ and those ‘wanting to know’.
So, whether you have experience in decentralised clinical trials or not, your contributions, experience, curiosity and innovation can be brought to discussion of:
- Sponsor Oversight
- Investigator Oversight
- Quality Assurance & Audit
- Operational Considerations
Each group will share its outputs with the whole group before a final wrap up, questions and answers.
Welcome & Introductions
CTD to CTR – Implications for Investigational Medicinal Product (IMP) Management to Ensure Regulatory Compliance
Michelle Yeomans, EPIC Auditors
Overview of IMP regulatory requirements and top tips for achieving compliance.
Clinical Trials, Inspections and Computerised Systems
Review of regulatory changes such as the implementation of, and practical experience with, the Clinical Trial Regulation in Europe, UK Clinical Trial Regulations, electronic data and data integrity considerations for clinical trials, recent inspection experiences and inspection findings
Upcoming regulatory changes and potential considerations for the implementation of ICH GCP (R3)
Practical ideas to improve consent by putting the patient at the centre of our considerations
Hugh Davies, Chair of Oxford “A” National Health Service Research Ethics Committee
Decentralised Clinical Trials Workshop
Panel Session, Final Q&A