Jean-Michel Cahen

IDMP Project Lead – RA Operations at Novartis Pharma AG, Switzerland

Speaker

Jean-Michel Cahen is currently the IDMP Project Lead at Novartis Pharma, working as Associate Director in Regulatory Affairs Operations within Global Drug Development in Basel, Switzerland.

With more than 20 years of experience at Novartis, he was involved in numerous strategic projects in Manufacturing and Regulatory through leading roles in QC/QA, Global Labelling, Regulatory CMC, EU Regulatory maintenance and Process Improvement.

He is leading the Regulatory Strategy and Intelligence for IDMP since 2014, contributes to the new Novartis MDM platform adoption for RA as well as the PLM (eAF) implementation.

Jean-Michel is an ad-hoc member of the PMS SME Support Team, the ISO Technical Committee 215 WG 6 for ISO IDMP and the PhRMA Regulatory IT Workgroup.