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.


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)