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Session 7, Track B: Responsible AI for Safer Medicines - Advancing Pharmacovigilance Quality and Decision Making in Latin America
Session Chair(s)
Juan Asbun, DRSc, MD
Pharmacovigilance and Patient Safety Regional Lead, Takeda México, S.A. De C.V., Mexico
Diana María Gonzalez, MD, MBA
Colombia PSL & PV Policy Lead Latam , Roche, Colombia
This session will examine the evolving landscape of pharmacovigilance inspections, audits, and inspection readiness across Latin America, with a focus on real-world impact rather than procedural checklists. Drawing on recent experiences from Health Authorities such as ANMAT, COFEPRIS, and ANVISA, the discussion will highlight common trends, inspection pain points, and expectations for both local and export markets. The session will also address the consequences of inspection findings in diverse regulatory environments and explore future directions, including digital systems, automation, and vendor oversight in emerging markets.
The Tech Expert: Concrete Applications of AI/ML for Advanced Signal Detection and PV Automation
Eleazar Coba, Bayer
Allan Nuno Alves de Sousa, ANVISA
From Blueprint to Reality: A Practical Roadmap for Evaluating and Integrating AI into Safety Workflows
Lina Valero, Opella Healthcare
Learning Objective : - Analyze concrete AI/ML applications transforming signal detection and PV risk management
- Align AI bioethics and quality standards with evolving regional regulatory expectations
- Design a practical action plan to safely integrate AI into existing safety communication workflows
Speaker(s)
Speaker
Allan Nuno Alves de Sousa
Deputy Director, Fifth Directorate, ANVISA, Brazil
From Blueprint to Reality: A Practical Roadmap for Evaluating and Integrating AI into Safety Workflows
Lina Valero, MD, MBA
Regional PV Head LATAM, Opella Healthcare, Colombia
The Tech Expert: Concrete Applications of AI/ML for Advanced Signal Detection and PV Automation
Eleazar Coba, MSc
Pharmacovigilance Officer, Bayer, Mexico
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