Martin O’Kane PhD is Regional Head of Regulatory Affairs EU Policy & Liaison at Novartis Pharmaceuticals, re-sponsible for developing and implementing complex regulatory strategies in global development and enabling regulatory compliance. He is co-chair of the European Federation of Pharmaceutical Industries Associations (EFPIA) EU Clinical Trials Regulation Pillar.
Martin has seventeen years’ previous experience in medicines regulation working in the Medicines and Healthcare products Regulatory Agency (MHRA), the majority of which was in the clinical trials field including scientific assessment of trial applications and development of policy, guidance, and legislation relevant to the UK’s exit from the EU and the UK response to COVID-19. Prior to Brexit, he was a member of the EU Heads of Medicines Agencies Clinical Trials Facilitation Group (CTFG) developing policy to harmonise trial processes and conduct throughout the EU and also EMA and European Commission expert groups on the implementation the EU CTR the clinical trials information system (CTIS).