Laurent Lefebvre

Regulatory CMC Associate Director at Novartis Pharma AG

Speaker

Pharmacist working as Director in RA GDD CMC at the Novartis HQ in Basel Switzerland. 10 years of experience working as worldwide Regulatory CMC Project Lead including blockbuster brands which helped to develop a good overview of the entire CMC product lifecycle in a global regulatory environment. Core team member of the Novartis Regulatory Strategy and Intelligence for IDMP since 2014 and member of the EFPIA ICH M4Q support team. Involved in regular collaborations cross-industry (IDMP roundtables, Pistoia Alliance), digital initiatives (RIM structured authoring, master data & PLM), reviewer of the ISO IDMP guidelines and Novartis contributor to regulatory intelligence discussions regarding telematics (EMA SPOR, KASA-PQ/CMC, G-SRS...), including contribution and review of EFPIA / Pharma position papers and currently acting as EFPIA Alternate Expert in the ICHM4Q(R2) EWG