EFGCP Summer Workshop
Proactive inspection readiness - anticipating future regulatory changes
Description
| Event | Workshop |
| Type | Face To Face |
| Language | English |
| Date(s) | 09 Jun. 2023 |
| Day(s) | 1 Day(s) |
| Duration | 1 Day |
This
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.
Programme
Friday 9 June 2023
| 10:30 |
Workshop Opening |
| 11:15 |
Welcome & Introductions |
| 11:30 |
Hot topics and issues for Investigational Medicinal Products (IMPs)
Michelle Yeomans, EPIC Auditors
|
| 12:00 |
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 |
|
| 13:15 |
Lunch |
| 14:00 |
Upcoming regulatory changes and potential considerations for the implementation of ICH GCP (R3) |
| 14:30 |
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
|
| 15:00 |
Decentralised Clinical Trials Workshop |
| 16:30 |
Workshop Feedback |
| 17:15 |
Panel Session, Final Q&A |
| 18:00 |
Close |