The Future of PV in the Era of Advancing AI Regulations: What QPPVs Must Know

WEBINAR OVERVIEW:
This live webinar, hosted by PrimeVigilance, will explore the rapidly expanding regulatory complexity that Qualified Persons for Pharmacovigilance (QPPVs) and Safety Leaders must navigate as artificial intelligence becomes increasingly embedded in pharmacovigilance (PV) operations. Attendees will gain practical insights into current AI adoption across PV workflows, emerging regulatory expectations from global health authorities, and the industry and legislative developments that are reshaping governance of AI-enabled systems in GxP environments. The session will also examine the changing responsibilities of QPPVs, highlighting why accountability remains with human oversight, how AI decision-making parameters should be defined and documented, and the latest regulatory lessons learned from inspections, enforcement actions, and evolving compliance requirements.

• Understanding of regulatory expectations for AI-enabled pharmacovigilance systems in 2026 and beyond
• Practical approaches to establish AI governance boundaries that maintain QPPV accountability
• Implementable strategies to align PV quality systems with the EU AI Act and pharma-specific regulations
• Insight into how Safety Leaders can proactively lead the transformation of pharmacovigilance operations
• Strategies to maintain inspection-ready AI governance through robust documentation, oversight and QPPV accountability

• QPPVs and Deputy QPPVs
• Heads/Directors of Pharmacovigilance and Drug Safety 
• PV Quality and Compliance Leaders 
• PV Operations Leaders 
• Quality Assurance / GxP Quality Professionals 
• Computerised Systems Quality / CSV Professionals 
• AI Governance and Compliance Professionals 
• Regulatory Affairs Professionals 
• Safety Technology / PV Systems Leaders