EFGCP On-line Seminar
Renovation and Regulation
| Event | Workshop |
| Type | Virtual Event |
| Language | English |
| Date(s) | 11 Sept. 2023 |
| Day(s) | 1 Day(s) |
| Duration | 1 Day |
Join us this autumn for a half day seminar on regulatory and ethical hot topics including practical considerations for ICH GCP E6(R3) Renovation, Investigational Medicinal Product (IMP) Regulations (EU and UK IMP considerations for compliance), an update from the MHRA GCP Inspectorate and ethical discussions on consent modernisation.
Programme
11 September 2023 - Half Day - CEST Time
| 13:30 |
Opening & Connection |
| 14:00 |
Workshop Introduction
Louise Mawer, Mirabilitas Ltd
Seif Eddine Amara Madi, GSK
|
| 14:20 |
CTD to CTR – implications for IMP management to ensure regulatory compliance
Michelle Yeomans, EPiC Auditors Ltd
|
| 14:55 |
Implications of ICH GCP E6(R3) for consent and other ethical issues
Hugh Davies, UK Health Research Authority
|
| 15.30 |
Break |
| 15:50 |
UK GCP Inspections Update
Michelle Gabriel, MHRA
|
| 16:30 |
Experience of EMA Guidance : computerised systems and electronic data in clinical trials
Seif Eddine Amara Madi, GSK
|
| 17:05 |
Panel Session & Q&A |
| 18:00 |
Wrap-up |
| 18:30 |
End (latest) |