The Center supports regulatory science research and hosts workshops, symposia, and other community-building and educational opportunities for the regulatory science community. Whether you are interested in regulatory science as a student, academic researcher, industry professional, or government professional, we welcome you to our community of enthusiasts.
Check out our Events for upcoming programming, stay updated on the latest news from the Center, or find out about local regulatory science opportunities, by signing up for our bimonthly mailing list. A few of our opportunities are highlighted below.
Pediatric Real-world Evidence Research
The Harvard-MIT Center for Regulatory Science, in close collaboration with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Boston Children’s Hospital, all at Harvard Medical School, is seeking a post-doctoral research fellow interested in the intersection of pediatric real-world evidence research with regulatory science. This includes pharmacoepidemiology research as it relates to the supplemental regulatory approval of medications for pediatric use. Up to 50% of medications in the outpatient setting and 80% in the inpatient setting are used off-label in pediatric patients. There is increasing interest in evaluating the suitability of real-world evidence studies to form the basis for supplemental regulatory approval of medications to be used in pediatric patients that were previously approved in adult patients. The fellow will conduct pediatric pharmacoepidemiology studies of medication safety and effectiveness using large claims and electronic health record data sources and studies how it impacts the regulation of medications in children.
The Division of Pharmacoepidemiology is internationally leading in training and research on the safety and effectiveness of medications applying advanced analytic methods to diverse large healthcare databases. It houses the FDA Sentinel Innovation Center and is working closely with FDA, EMA and NIH on a range of projects relevant to regulatory science. For this position, the fellow will work directly under the mentorship of Drs. Sebastian Schneeweiss and Tim Savage and with Dr. Florence Bourgeois, Co-Director of the Harvard-MIT Center for Regulatory Science. The fellow will be expected to participate in international conferences and publish conference and journal papers
- Individuals with doctoral degrees (MD, PhD, PharmD, or equivalent) and training or experience in healthcare data science, clinical pediatrics, clinical pharmacology, pharmacoepidemiology, epidemiology, or health services research
The FDA and Prescription Drugs: Current Controversies in Context
This free, self-paced, six-session online course will cover pharmaceutical product development, approval, marketing, and costs, as well as an overview of FDA and the major issues affecting regulatory approval and evidence-based use of prescription drugs. For more information on the course material, watch this introductory video here. The course is run by the Program on Regulation, Therapeutics, and Law (PORTAL), a CRS partner program, in conjunction with HarvardX/edX, and is currently ongoing.