Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

This session will delve into the challenges and opportunities around effectiveness of Risk Minimisation Measures, with a focus on evolving regulatory expectations and practical methodologies. We will explore updates to GVP Module XVI, examine commonly used approaches such as drug utilisation studies and PASS studies, and reflect on lessons learned from industry and academic experience, including impact studies conducted per PRAC requests. Discussion will also address the real-world impact of RMMs in clinical practice, the objectives we aim to achieve, and the challenges posed by personal data protection and other regulatory requirements. Join us as we unpack the complexities of evaluating RMM effectiveness and work toward improving patient safety outcomes.