OCM Director – Regulatory Science Europe at Critical Path Institute (C-Path)


Cécile is a senior health engineer with over 15 years of global drug development experience particularly in children and rare disease. Prior to joining Critical Path Institute as a Regulatory Science Advisor, Cécile was Chief Operating Officer at Aparito a medtech company developing digital endpoints, and was 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 recognised for her work leading the EMA extrapolation global strategy and activities including the EMA/FDA harmonisation for Gaucher disease and global harmonisation 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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