Stella Blackburn has spent over 30 years in pharmacovigilance and pharmacoepidemiology in both regulatory and industry environments. Trained in medicine at Cambridge and London Universities she has an MSc in epidemiology from the London School of Hygiene and Tropical Medicine. At the European Medicines Agency she was responsible for developing risk management for Europe and was the lead author of the guidelines. She is passionate about optimizing the benefit risk balance of medicines and to helping bring medicines to patients with unmet medical needs – particularly those with rare diseases. She is a Visiting Scientist at the Center for Biomedical Innovation, Massachusetts Institute of Technology where she continues work on innovative methods for bringing medicines to market. She is a Fellow of the Royal College of Physicians of Edinburgh and a Fellow and Past President of the International Society of Pharmacoepidemiology.