Dr Stella Blackburn is currently Vice President, Global Head of Risk Management at Quintiles. Following medical training at Cambridge University and Guy’s hospital, Stella worked in hospital medicine before joining the pharmaceutical industry. There, she spent 11 years in pharmacovigilance and pharmacoepidemiology, gaining a MSc in Epidemiology from the London School of Hygiene and Tropical Medicine before moving to the European Medicines Agency in 1997 to continue work in pharmacovigilance. For the last 10 years at the EMA, Stella was responsible for developing EU policy on risk management, writing the EU guidelines on this topic and more recently helping to implement the 2010 PhV legislation. Stella is a Fellow of the International Society of Pharmacoepidemiology (ISPE), the Royal College of Physicians of Edinburgh and the Faculty of Pharmaceutical Medicine. She is a past President of ISPE – the first regulator to hold this post – and an honorary lecturer at the London School of Hygiene and Tropical Medicine.