11.30am – 11.45am GMT, 6 November 2024 ‐ 15 mins
Presentation
Session One: The UK as a global attractive destination for clinical trials
Session Chair: Dr Martin O’Kane, Regional Head Regulatory Affairs EU Policy & Liaison, Novartis, and Member, BIA Regulatory Affairs Advisory Committee
Regional Head of Regulatory Affairs EU Policy & Liaison, Novartis Pharmaceuticals
Head of Policy and Engagement, Health Research Authority
Clive Collett is the Head of Policy & Engagement within the Health Research Authority’s Policy & Partnerships Directorate. He has over 25 years of experience of research regulation and research ethics committees within the NHS. He is currently involved in the update to the UK’s Clinical Trials Regulations, including the introduction of new research transparency requirements. He has a biology degree, PgDip in Healthcare Ethics and an MA in Medical Ethics & Law. He is a lay member of the Ministry of Defence Research Ethics Committee (MODREC).
Regional Head of Regulatory Affairs EU Policy & Liaison, Novartis Pharmaceuticals
Martin O’Kane PhD is Regional Head of Regulatory Affairs EU Policy & Liaison at Novartis Pharmaceuticals, responsible 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) Clinical Trials Regulation Pillar and is a member of the BIA Regulatory Affairs Advisory Committee. 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.