SC-03 - Regulatory Pharmacoepidemiology

Friday, August 22, 2025

9:00 AM - 12:30 PM ET

Location: Room 204 ABC

Presenting Author(s)

Danica Marinac-Dabic, MD, PhD, MMSc, FISPE (she/her/hers)

Associate Director,
FDA/CDRH/ Office of Clinical Evidence and Analysis , United States

Co-Author(s)

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology
US Food and Drug Administration, United States
PV

Patrice Verpillat, MD, MPH, PhD

Head of Real World Evidence
European Medicines Agency, Netherlands

COURSE

Description: We will engage the course participants in an interactive learning about key aspects of pharmacoepidemiology from a point of view of a regulator. Specific attention will be given to uniqueness of the state of the science in drugs-, devices- and biologics- epidemiology including current differences/potential for convergence in the international regulatory setting. The session is constructed as a dynamic combination of a didactic work and work on case examples in order to maximize the learnings, knowledge retention and networking among participants. The faculty will also discuss the role pharmacoepidemiology plays in regulatory determinations globally, including the opportunities for epidemiologists in the context of recent regulatory convergence and reliance efforts. Following the didactic part of the course the participants will engage interactively in a series of test cases facilitated by the faculty. Finally, the participants will be given opportunity to shape up the next year course by sharing their ideas about the content and desired format.