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Kirsty Wydenbach

Senior Medical Assessor and Deputy Unit Manager, Clinical Trials Unit at MHRA, UK

Profile

Kirsty joined the MHRA in 2009 as a Medical Assessor in the Clinical Trials Unit. She has been specifically involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for both chemical and biological products, Advanced Therapy Products and many first-in-man studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to decisions regarding clinical trials, particularly for Developmental Safety Update Reports (DSURs) and also including Voluntary Harmonised Procedure (VHP) applications. More recent EU priorities have included the new Clinical Trial Regulation and Kirsty currently sits on the safety subgroup of the Clinical Trials Facilitation Group (CTFG) that is working on how this will be implemented. She is also the co-chair for safety for the EU NTC Curriculum for European regulatory agency assessors and was an EMA expert for the update of the First-in-Human guideline.

Agenda Sessions