Christelle Bouygues

Christelle Bouygues

EMA EUROPA

Senior Regulatory Affairs Officer at the European Medicines Agency. The EMA Regulatory Affairs Office is responsible for providing regulatory intelligence and advice in relation to the development, evaluation and surveillance of medicinal products for human use submitted through the Centralised Procedure (including scientific advice, orphan, and paediatric) and to its Committees.

Christelle was involved in particular with the implementation of the paediatric and pharmacovigilance legislation. Christelle has coordinated the implementation of the MDR/IVDR within EMA. Christelle is also closely involved in the repurposing of medicines. She was the EMA representative at the 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 Spain. Christelle is coordinating as well the EU repurposing pilot at the EMA. Before joining the Agency, Christelle gained a 4-year experience at the French Competent Authority (ANSM) in the Mutual Recognition Procedures and Oncology Evaluation services and had a 2-year experience in the pharmaceutical industry.

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