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Session 1: Current Developments in Clinical Trial Disclosure - Europe
Session Chair(s)
Matthias Zerm, PHD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Germany
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
In March 2023 the UK MHRA announced that it will streamline clinical trial approvals in the biggest overhaul of trial regulation in 20 years. Learn about the latest developments regarding the new legal framework, new clinical trial disclosure requirements, and new comprehensive guidance to accompany the new legislative measures.
The implementation of EUDAMED in the context of the EU MDR has been delayed, with the new go-live date expected in Q2 2024. Mandatory use of the database will begin in Q4 2024 for registration, clinical investigations, performance studies, vigilance and post-market surveillance. Hear the latest updates on EUDAMED’s Clinical Investigations and Performance Studies module and the related transparency aspects.
Speaker(s)
UK Update
Clive Collett
Health Research Authority, United Kingdom
Interim Head of Policy and Engagement at the HRA
EU MDR CIPS Module - An Update
Joyce Swart
Alcon Research, LLC, United States
Director, Clinical Trial Disclosure