ServierNon Clinical Studies Manager
Nov. 2002 - Jul. 2015Metabolism and cardiology therapeutic areas Participation to Development plan elaboration Clinical biomarkers studies (Phases II and III) Regulatory activities: rédaction of IB, briefing Books, PIP, Orphan Drug designation, CTD BLA/NDA Non clinical studies management: pharmacological, toxicological, pharmacokinetic, analytical Phase I studies : FIH, DDI, PKH Préparation of post Launch supports Licencing-in: scientific evaluation