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avatar for Kirsty Wydenbach

Kirsty Wydenbach

MHRA
Deputy Unit Manager, Clinical Trials Unit
Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy Products and many first-in-man studies. Also participated in European discussions aiming to establish an EU harmonised approach to clinical trials. 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. She is an author on the upcoming ECMC consensus paper on complex innovative trials and a contributor to the EU CTFG discussions on adaptive design trials.