“The Future of PV in the Era of Advancing AI Regulations: What QPPVs Must Know”
Wednesday, October 21, 2026 | 12am EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central)
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As artificial intelligence becomes increasingly embedded in pharmacovigilance operations, QPPVs and Safety Leaders face a new challenge: how to embrace AI-driven innovation while maintaining regulatory compliance, effective oversight and clear human accountability.
Join PrimeVigilance experts Jana D’Alascio, Senior Director, QPPV, and Nikodem Latocha, Associate Director Quality – Computerized Systems Quality, for a practical discussion on the evolving regulatory landscape for AI-enabled pharmacovigilance.
The session will explore current AI adoption across PV workflows, emerging expectations from global health authorities and the implications of the EU AI Act and other evolving requirements for GxP environments. Our experts will also examine what these developments mean for the role of the QPPV, including how organizations can establish appropriate governance boundaries, define and document AI decision-making parameters, and remain inspection-ready as technology continues to evolve.
Join our Expert Speakers
Jana D’Alascio
Senior Director, QPPV
PrimeVigilance
Nikodem Latocha
Associate Director Quality – Computerized Systems Quality
PrimeVigilance
What You’ll Learn:
- How regulatory expectations for AI-enabled pharmacovigilance systems are evolving in 2026 and beyond
- How to establish clear AI governance boundaries while maintaining QPPV accountability and human oversight
- Practical considerations for aligning PV quality systems with the EU AI Act and pharma-specific regulatory requirements
- How robust documentation, oversight and governance can help maintain inspection readiness
- How QPPVs and Safety Leaders can proactively prepare their PV operations for increasing adoption of AI
As AI continues to transform pharmacovigilance, organizations need governance models that enable innovation without compromising quality, compliance or accountability.
Register now to secure your place.
