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Session 2, Track C: Transform PV Workflows: Driving Innovation with AI and Automation to Solve Increasing Demandn
Session Chair(s)
Daniel Greco, PharmD, MS, RPh
Associate Director of Patient Safety, Bristol-Myers Squibb Company, 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.
Learning Objective : At the conclusion of this session, participants should be able to: - Differentiate AI-native vs. AI-augmented PV workflows and explain structural advantages for auditable regulatory compliance
- Assess AI outputs against 4 auditability criteria (traceability, justification, completeness, documentation) using a practical example
- Identify workflow or governance changes needed to implement compliant AI-enabled PV processes within their organization
Speaker(s)
Raghavendra Parvataraju, MBA
CEO, Graph AI, United States
Scaling AI in Pharmacovigilance: Real-World Application of AI/ML to Solve Increasing Demands In PV Workflows
Ann Mary Thomas, PharmD
Sr. Specialist- Clinical Literature Monitoring, Ephicacy Canada, Canada
Auditability in AI-Assisted Clinical Literature Monitoring: Are We Inspection-Ready?
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