Christelle Bouygues

Senior Regulatory Affairs Specialist - EMA EUROPA

Christelle works in the Regulatory Affairs Office at the European Medicines Agency(EMA) since 2004. As EMA Regulatory Affairs Officer, Christelle is responsible for providing regulatory advice in relation to regulatory matters for medicinal products for human use submitted through the Centralised Procedure. She has, in particular, an active role on topics such as the implementation of the MDR/IVDR requirements for combination products and repurposing of medicines within EMA.

Christelle is closely involved with the EU medicines repurposing pilot conducted by EMA and the network. She was also at the time the EMA representative at Commission Expert Group on Safe and Timely Access to Medicines for Patients (“STAMP”) for the repurposing topic and subsequently became the EMA representative at the Repurposing Observatory Group, which she is now co-chairing with the Spanish Competent Authority.