Dr. Bourgeois, MD, MPH is Associate Professor of Pediatrics at Harvard Medical School and Co-Director of the Harvard-MIT Center for Regulatory Science. At Boston Children’s Hospital, she directs the Initiative in Pediatric Therapeutics and Regulatory Science. Dr. Bourgeois’ research is focused on the regulation and use of medications in children and the evaluation of gaps in pediatric drug evidence at the point of care. She has led studies investigating the development of drugs and devices in pediatric populations, the quality of pre-market pediatric safety and efficacy assessments, and the development of standardized metrics to assess the impact of FDA’s regulatory programs on pediatric product information. She is the recipient of an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund to evaluate the epidemiology of off-label drug and biologic use in children and improve provider access to benefit-risk information on FDA-regulated products. Most recently, Dr. Bourgeois served as an Expert Visitor to the European Medicines Agency to analyze the EU’s pediatric drug legislation.