Understanding the FDA’s AI Guidance in Pharmacovigilance

In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the FDA’s first draft guidance for AI in drug development, published in January 2025, with Archana Hegde, senior director, pv systems and innovations at IQVIA.

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In this episode of Denatured, Archana Hegde from IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA’s first draft guidance for AI in drug development, published in January 2025. Hegde explains that the vagueness of the current framework is like “a recipe with no pictures and mystery ingredients.” During the discussion, she highlights areas of existing confusion.

This episode is presented in partnership with IQVIA.

Host

⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guest

Archana Hegde, Senior Director, PV Systems & Innovations, IQVIA

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Lori Ellis is the Head of Insights at BioSpace. She analyzes and comments on industry trends for BioSpace and clients. Her current focus is on the ever-evolving impact of technology on the pharmaceutical industry. You can reach her at lori.ellis@biospace.com. Follow her on LinkedIn.
The BioSpace Insights teams performs research and analysis on industry trends for BioSpace and clients, producing industry reports, podcasts, events and articles.
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