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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
Pharmacovigilance and Patient Safety Regional Lead, Takeda México, S.A. De C.V., Mexico
Diana Gonzalez, MD, MBA
Colombia PSL & PV Policy Lead Latam , Roche, Colombia
Artificial intelligence is rapidly transforming pharmacovigilance across Latin America, redefining how drug risks are identified, analyzed, and communicated throughout their lifecycle. This symposium examines the emerging role of AI and machine learning in enhancing—rather than replacing—scientific, clinical, and regulatory judgment within the regional healthcare ecosystem. Key discussions will address practical applications like automated signal detection, process optimization, and the evaluation of risk minimization strategies. Finally, the panel will confront the unique quality, bioethical, and regulatory compliance considerations necessary to deploy AI responsibly for safer medicines in the region.
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)
Lina Valero, MD, MBA, MSc
Regional PV Head LATAM, Opella Healthcare, Colombia
From Blueprint to Reality: A Practical Roadmap for Evaluating and Integrating AI into Safety Workflows
Representative Invited
Pharmacovigilance Officer, Bayer, Mexico
The Tech Expert: Concrete Applications of AI/ML for Advanced Signal Detection and PV Automation
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