Shelley Gandhi is a renowned pharmacovigilance expert. Currently leading the Pharmacovigilance and Drug Safety team at NDA Group, Europe’s leading regulatory drug development, pharmacovigilance and HTA consultancy, she has over 20 years of experience in this area. Between 1993 and 2012 she held various senior-level positions at the Medicines and Healthcare products Regulatory Agency (MHRA). She was one of the key drivers in ensuring MHRA’s compliance with the new pharmacovigilance legislation, having vast knowledge in regulatory requirements, risk minimisation strategies, signal detection and management as well as other areas of drug safety. While at MHRA Shelley represented the agency at various international meetings and working groups, including the EMA Eudravigilance Expert Working Group and Eudravigilance Telematics Implementation Group. Shelley Gandhi completed her BSc in Biochemistry at Queen Mary, University of London and MSc in Biopharmacy at Kings College London. She received post graduate certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine, University of London.