Regulatory Science Advisor, Director NL
Critical Path Institute
Cécile is a senior health engineer with over 15 years of experience in global drug development, particularly for paediatric and rare diseases. Prior to joining Critical Path Institute, Cécile was with a medical technology company developing digital endpoints and for 11 years a scientific officer at the European Medicines Agency (EMA). At EMA, she provided technical and regulatory expert guidance on the design, conduct and interpretation of paediatric developments across multiple therapeutic areas. Cécile has been recognized for her work leading the EMA extrapolation global strategy and activities including the EMA/FDA harmonization for Gaucher disease and global harmonization of criteria for development in paediatric Pulmonary Arterial Hypertension (PAH) with patients, healthcare professionals, with FDA and Health Canada.
She was also an expert in the E11 R(1) working group and the paediatric standing group for the International Conference of Harmonization (ICH)
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Thursday, May 12, 2022
8:00 AM – 12:00 PM ET
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