Dr Carole Légaré completed her medical training at the University of Ottawa, and her postgraduate pharmacoepidemiology and pharmacovigilance training at the London School of Hygiene and Tropical Medicine in the UK. After gaining experience in clinical practice and public health, she joined Health Canada in 2002 where she initially worked in pharmacovigilance. She also worked as a senior medical advisor for the Centre for Biologics Evaluation during the H1N1 influenza pandemic. In 2013, she joined the Therapeutic Products Directorate as the Director of the Office of Clinical Trials, where she oversees all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals. She is currently a member of the ICH E8 working group on General Considerations for Clinical Studies.