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

Wednesday, October 14  | 10:20 a.m.

Speaker:
Julie Girod, Associate VP, Global Head of Case Management and Medical Evaluation, Sanofi

Second speaker:
John Regan, VP Customer Success, IQVIA

In this keynote case study, Sanofi and IQVIA share the real story behind Project ARTEMIS: moving from a heavily customized legacy PV landscape to a production-grade, enterprise-scale operating model that uses governed, human in the loop AI to drive speed and consistency while protecting quality and compliance. We’ll unpack what it took to deliver at Tier 1 scale, the governance decisions that mattered most, and the implementation lessons others can apply—whether you’re exploring automation in intake or aiming for end-to-end modernization.

Hype to Impact: A smart-touch Approach to Operationalizing AI in PV with Audit-Ready Oversight

Wednesday, October 14 | 11:45 a.m.

Speaker:
Archana Hegde, Senior Director, PV Systems & Innovations, Lifecycle Safety, IQVIA

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.

Taking Control of Safety: The Shift to Sponsor-Owned PV Platforms

Wednesday, October 14 | 11:45 a.m.

Speaker:
Chetan Yavasani, Global Head of Product, IQVIA Vigilance Platform, IQVIA

Many emerging biopharma and small companies have historically relied on CROs for pharmacovigilance systems, gaining speed and cost efficiency but limiting access to critical data. In today’s environment, lack of timely, comprehensive data and control over the information lifecycle creates clear disadvantages across clinical and post-marketing safety.

As companies grow and complexity increases, these constraints drive higher costs and operational challenges. As a result, more organizations are shifting toward sponsor-owned PV platforms—not just systems to manage processes, but modern platforms that enable AI and provide faster, higher-quality data access.

This session explores when it makes sense to invest in a dedicated safety platform, how requirements evolve as teams scale, and how ownership can enhance transparency, strengthen risk management, and support long-term flexibility. We will also discuss how more standardized, right-sized approaches are lowering barriers, making it practical for lean teams to establish an audit-ready PV foundation earlier.

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

Thursday, October 15 | 11:05 a.m.

Speaker:
Scott Fonseca,Vice President and Managing Director, Integrated Safety, IQVIA

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.

Key discussion topics:

• What established GxP principles remain relevant in the age of GenAI, and what is needs to evolve?
• Risk before controls. How risk assessment should drive governance, validation, monitoring and oversight decisions.
• Beyond human-in-the-loop. Building governance models that are evidence-based, scalable and proportionate to risk.