As real-world evidence becomes increasingly central to regulatory and safety decision-making, this course builds on foundational knowledge to develop deeper expertise in pharmacoepidemiological methods. Students will learn common approaches to identify and address confounding and bias; appraise evidence across study designs and data sources; and apply insights to regulatory processes. Through real-world case studies and simulated safety scenarios, the course equips students to critically evaluate and apply evidence in complex decision-making environments.

This course can be taken as a standalone course or as the third in a series of courses that form the Professional Certificate in Pharmacoepidemiology & Pharmacovigilance.