Christelle Bouygues, PharmD

Senior Regulatory Affairs Specialist
EMA, Netherlands

Senior Regulatory Affairs Specialist 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.

Presentation(s):

• Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)

  Tuesday, September 17, 2024
  8:30 AM – 4:00 PM PDT

• The European Pharmaceutical Legislation Revision – Status Update and Ongoing Challenges

  Thursday, September 19, 2024
  9:15 AM – 10:30 AM PDT

• Precision Medicine Using Companion Diagnostics, AI/ML Modeling, and Digital Health Technology? Buzzwords or Reality?

  Thursday, September 19, 2024
  3:15 PM – 4:15 PM PDT