Barry Mulchrone
Head of Safety Science & Strategy,
Lifecycle Safety
IQVIA

Howard Snow, MD
VP Head of Global Pharmacovigilance
and Patient Safety
SOBI

September 23

11:40 - 12:00

Hype to Impact: A smart-touch approach to operationalizing AI in PV with audit-ready oversight

AI is moving fast in pharmacovigilance, but scaling it safely is where most programs stall. In this session, you will learn how to move from pilot to measurable impact using a smart-touch approach: apply AI to accelerate repeatable, high-volume work while keeping qualified experts accountable for scientific judgment and final decisions. We will share practical patterns PV and safety leaders can use to operationalize AI with audit-ready oversight, including clearly scoped “context of use,” human-in-the-loop checkpoints, risk-based validation, and traceable evidence showing what AI did and what humans approved.

Updesh Dosanjh
Practice Leader,
Pharmacovigilance Technology Solutions
IQVIA

September 23

16:05

From Promise to Proof: How Sanofi Operationalized Governed AI in Pharmacovigilance at Global Scale

TBA

September 23

17:50

 Human-in-the-Loop Is Not a Governance Strategy

Human oversight has become the default answer to almost every AI governance question in Pharmacovigilance. Yet adding humans to a process does not automatically reduce risk and, in some cases, may increase it. GxP organisations have always understood that controls must be driven by risk, not assumption.

As AI adoption accelerates, the most effective governance models will not be those with the most review checkpoints, but those with the clearest understanding of failure modes, consequences, detectability, and control effectiveness.