Understanding the FDA’s AI Steering in Pharmacovigilance
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On this episode of Denatured, Archana Hegde from IQVIA discusses the sensible challenges confronted by pharmacovigilance (PV) professionals as they navigate the FDA’s first draft steering for AI in drug growth, printed in January 2025. Hegde explains that the vagueness of the present framework is like “a recipe with no photos and thriller elements.” Through the dialogue, she highlights areas of present confusion.
This episode is offered in partnership with IQVIA.
Host
Lori Ellis, Head of Insights, BioSpace
Visitor
Archana Hegde, Senior Director, PV Techniques & Improvements, IQVIA
Disclaimer: The views expressed on this dialogue by company are their very own and don’t signify these of their organizations.
