Christelle Bouygues

Regulatory Affairs Officer - 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 the development, evaluationand surveillance of medicinal products for human use submitted through the Centralised Procedure.

Christelle is also closely involved with the medicines repurposing topic. She was 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. Christelle is coordinating as well the EU repurposing pilot at the EMA. Christelle has as well a coordinating role for the implementation of the MDR/IVDR within EMA as regards to matters related to medicines used in combination with medical devices.