Understanding the FDA's AI Guidance in Pharmacovigilance
- Author
- BioSpace
- Published
- Tue 01 Jul 2025
- Episode Link
- https://podcasters.spotify.com/pod/show/biospace/episodes/Understanding-the-FDAs-AI-Guidance-in-Pharmacovigilance-e34udjl
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IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA's first draft guidance for AI in drug development, published in January 2025.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.
