Latin America Annual Meeting

This session addresses the critical challenges in translating global Risk Management Plans (RMPs) and additional Risk Minimization Measures (aRMMs) from regulatory documents into effective, real-world actions for patient safety across Latin America. We will explore collaborative strategies for achieving regional harmonization and regulatory alignment of RMPs and aRMMs, focusing on the adaptation of global strategies to diverse local contexts, particularly where specific local guidelines are lacking. The discussion will include practical studies on the lifecycle integration, effective design, and implementation of additional RMMs, alongside methods for measuring their impact and effectiveness on patient outcomes. Participants will co-create an abstract of actionable insights to move beyond mere compliance to achieve tangible and measurable risk mitigation in the LatAm region.