Event
FDLI Enforcement, Litigation and Compliance Conference
December 4 - December 5, 2025
Washington, D.C.
FDLI’s scope covers all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities in the U.S. and globally, including drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. The FDLI community includes manufacturers, distributors, law firms, consultants, academics, government employees, non-profits, and students. Collectively, the stakeholder group engaged with FDLI is 30,000+ individuals.
Expecting 150-200 experts who work in heavily regulated industries, particularly those in the drug, device, food, and tobacco sectors such as compliance officers, legal counsel, regulatory affairs, risk and quality management.
Tala H. Fakhouri, Ph.D., M.P.H.
Vice President Consulting, AI & Digital Policy, Real-World Research
Thursday, Dec. 4 from 11:20 – 12:20p.m.
Title – Smart Compliance, Smarter Enforcement: AI in Industry and at FDA
As industry increasingly deploys AI tool in quality systems, regulatory submissions, and compliance workflows, new challenges are emerging around data integrity, audit trails, and model transparency. At the same time, FDA is expanding its own use of AI – including the Elsa tool – to identify violations, detect data anomalies, and support enforcement actions, as seen in its recent case against Raptim Research. This session will explore how AI is transforming both sides of the regulatory equation, offering practical strategies for managing risk, ensuring trustworthy data practices, and preparing AI-driven scrutiny across FDA-regulated industries.
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