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Session 9, Track B: Modernizing Pharmacovigilance - Strategies to Strengthen Maturity, Consistency, and Global Alignment in LatAm
Session Chair(s)
Lina Valero, MD, MBA
Regional PV Head LATAM, Opella Healthcare, Colombia
Monica Darinka Ramirez Quiroz
Drug Safety Sr. Director, MSD, Mexico
This session will explore the current PV landscape in LatAm, highlighting key challenges and opportunities across the region. Discussions will include regulatory diversity, operational complexities, and the degree of alignment with global PV requirements. Panelists will also examine how organizations are navigating these differences while ensuring compliance, maintaining data quality, and strengthening patient safety outcomes. Special attention will be given to the maturity of PV systems across LatAm markets and the strategies being implemented to bridge gaps, foster regional collaboration, and enable sustainable growth.
Learning Objective : At the conclusion of this session, participants should be able to: - Assess LatAm PV landscape including regulatory variability, system maturity and market challenges
- Analyze operational and compliance issues across LatAm
- Evaluate alignment with global PV standards and harmonization opportunities
- Identify strategies to strengthen PV maturity through capability building, process optimization and collaboration
Speaker(s)
Speaker
Cinthya Galicia
Sr. Manager Country Safety Lead, Pfizer, Mexico
Speaker
Representative Invited
Head of Global Pharmacovigilance Operations, Moderna, United States
Speaker
Helaine Capucho, DRSc
Market Access Director, Interfarma, Brazil
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