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Christelle Bouygues, PharmD

Regulatory Affairs Senior Officer
EMA, Netherlands

Regulatory Affairs Senior 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, paediatric, SME) and to its Committees.
Christelle was involved in particular with the implementation of the paediatric and pharmacovigilance legislation. Currently, amongst other projects, Christelle is closely involved in the implementation of the MDR/IVDR within EMA as regard to the aspects on medical devices used in combination with medicinal products. Before joining the Agency, I gained a 4-year experience at the French Competent Authority, in the Mutual Recognition Procedures and the Oncology Evaluation services, and had a 2-year experience in the pharmaceutical industry.

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Presentation(s):