SAFETY360°: DIA Conference on Clinical & Post-Market Safety

Session Overview: AI in Pharmacovigilance session provides drug safety professionals with a forward-looking perspective on how artificial intelligence is reshaping PV practices across the safety lifecycle. Moving beyond pilots and experimentation, the session focuses on what it takes to deploy AI with confidence, control, and measurable impact in regulated pharmacovigilance environments. The session opens with an expert perspective on the evolution of AI in PV, highlighting why the industry has reached a pivotal inflection point. This sets the stage for a high-impact panel discussion on agents with agency—AI systems that can reason, critique, and adapt across PV workflows. The discussion explores organizational readiness, regulatory expectations, validation, and the balance between system autonomy and human oversight. The session concludes with a real-world case study demonstrating how AI can be operationalised at scale in pharmacovigilance, translating strategic vision into production-ready deployment while maintaining quality, compliance, and auditability. Session delivers a cohesive narrative that blends strategic insight, regulatory realism, and operational depth—making this session essential for leaders and decision-makers shaping the future of pharmacovigilance, patient safety, and AI-enabled risk management at enterprise scale.