AI, Regulation and Sustainability in Drug Development

Oct 28, 2026
Clinical Trials
This session explores how regulators are shaping the use of artificial intelligence in drug development. It covers FDA's framework for assessing AI credibility, what FDA and EMA expect organizations to have in place, and how other regulators are approaching AI oversight. The session closes with recommendations for sponsors and vendors.
 
Participants will leave with:
  • An understanding of FDA's framework for assessing AI credibility
  • A picture of what regulators expect
  • A view of how global approaches compare
  • Practical recommendations for sponsors and vendors
Speakers
Maria Florez
Maria Florez, Senior Consultant - Tufts