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Session 2, Track C: Transform PV Workflows: Driving Innovation with AI and Automation to Solve Increasing Demand
Session Chair(s)
Daniel Greco, MS
Risk Management Lead, Sanofi Canada, Canada
Anna Bussel, PharmD
Vice President Pharmacovigilance and Medical Information, ClaroPV Services Inc, Canada
Pharmacovigilance teams are facing unprecedented pressure from rising case volumes, increasing data complexity, and expanding regulatory expectations - challenging traditional, manual workflows. This session explores how AI and automation can transform PV operations, moving beyond efficiency gains to enable scalable, compliant, and audit-ready processes across the safety lifecycle. Through real-world examples in clinical literature monitoring and practical frameworks, speakers will highlight both the opportunities and current limitations of AI, particularly, in traceability, justification, and reproducibility that remain despite structured outputs, requiring standardized frameworks, robust validation, and continued human oversight. Participants will gain insights into how innovative system design, governance, and human-AI collaboration can drive sustainable transformation while maintaining regulatory confidence.
Scaling AI in Pharmacovigilance: Real-World Application of AI/ML to Solve Increasing Demands In PV Workflows Vijay Ponukumati, Graph AI
Auditability in AI-Assisted Clinical Literature Monitoring: Are We Inspection-Ready? Ann Mary Thomas, Ephicacy Pvt Ltd
Best Practices for AI Governance in Pharmacovigilance Aise Sukran Renda, Turkish Medicines and Medical Devices Agency (TITCK)
Learning Objective : At the conclusion of this session, participants should be able to: - Describe how AI can be responsibly leveraged within increasingly complex pharmacovigilance (PV) workflows, using a specific application such as aggregate reporting or signal management
- Identify common gaps between current AI capabilities and regulatory expectations in Clinical Literature Monitoring
- Anticipate the key areas of focus for inspectors when assessing AI systems implemented in PV
Speaker(s)
Scaling AI in Pharmacovigilance: Real-World Application of AI/ML to Solve Increasing Demands In PV Workflows
Vijay Ponukumati, MSc
CTO, Graph AI, United States
Auditability in AI-Assisted Clinical Literature Monitoring: Are We Inspection-Ready?
Ann Mary Thomas, PharmD
Sr. Specialist- Clinical Literature Monitoring, Ephicacy Canada, Canada
Best Practices for AI Governance in Pharmacovigilance
Aise Sukran Renda, MBA
Senior Inspector, Chair of PIC/S AI/ML Working Group, Turkish Medicines and Medical Devices Agency (TMMDA), Turkey