Latin America Annual Meeting

Pharmacovigilance (PV) systems in Latin America are increasingly shaped by evolving regulatory expectations, rising inspection scrutiny, and the adoption of more complex organizational and operating models. As companies expand regionalized structures and outsourcing strategies, ensuring effective safety governance, clear accountability, and sustained regulatory compliance has become more challenging across the region. This session will explore the current landscape of safety governance and oversight in LATAM, including the role of QPPV and local PV responsible functions, organizational models, and cross-functional alignment. Key topics will include governance challenges associated with regionalization, interactions with health authorities, outsourcing risks, and the increasing scrutiny of organizational structures during regulatory inspections. Building on this foundation, the discussion will focus on practical approaches to strengthening PV governance frameworks, improving oversight across distributed models, and aligning global expectations with local regulatory requirements. Additional areas will include PSMF governance and harmonization, performance metrics and system effectiveness, and the impact of public and private market access models on PV obligations. Through expert perspectives and real-world examples, participants will gain actionable insights into how to design and operate effective PV governance systems in a complex and evolving regional environment.