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Session 4, Track B: Collaborative Risk Management and Lifecycle Safety Strategies - Translating Paper into Action for LatAm Patient Impact
Session Chair(s)
Cinthya Galicia
Sr. Manager Country Safety Lead, Pfizer, Mexico
Diana Gonzalez, MD, MBA
Colombia PSL & PV Policy Lead Latam , Roche, Colombia
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.
Learning Objective : At the conclusion of this session, participants should be able to - Analyze gaps between global RMP and aRMM strategies and local LatAm regulatory requirements to identify harmonization opportunities
- Formulate a structured approach for lifecycle integration and practical design of effective aRMMs adapted to the LatAm patient context
- Measure the effectiveness of implemented aRMMs by applying key performance indicators for tangible risk mitigation
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