Prof Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems and processes. Dr Lewis is the author of papers on the safety of medicines as well as research papers on neuropharmacology. He is Visiting Professor, School of Life and Medical Sciences, University of Hertfordshire, a member of the ICH E2D(R1) Expert Working Group, was Project Coordinator for the IMI WEB-RADR 2 consortium, and is Work Package Co-Leader for IMI ConcePTION.