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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IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA's first draft guidance for AI in drug development, published in January 2025.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.

Understanding the FDA's AI Guidance in Pharmacovigilance

BioSpace

Understanding the FDA's AI Guidance in Pharmacovigilance