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Home  >  Speakers  >  Kirsty Wydenbach
Kirsty Wydenbach

Kirsty Wydenbach

London, England    United Kingdom
Pharmacy And Medicine
Pharmacy And Medicine, Clinical Trials,...More
Spoken at 3 events

Biography :

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.

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Pharmacy and Medicine

Interested Topics

Pharmacy and Medicine, Clinical Trials, Clinical Research, Internal Medicine, Clinical Pharmacology, Infectious Diseases, Oncology, Pharmacovigilance, Regulatory Submissions, Regulatory Affairs

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