Event
FDLI Enforcement, Litigation and Compliance Conference
December 4 - December 5, 2025
Washington, D.C.
The FDLI Enforcement, Litigation, and Compliance Conference, held in December in Washington, DC, is a key annual event that brings together legal, regulatory, and compliance professionals from across the FDA-regulated industries. The conference focuses on current enforcement trends, litigation developments, and compliance strategies, offering insights from government officials, industry experts, and legal practitioners. It provides a valuable platform for networking, thought leadership, and staying informed on the evolving regulatory landscape, with both in-person and virtual attendance options available.
Schedule a meeting below and meet our site experts at the Parexel booth! You can also join our session – details are listed below!
Tala H. Fakhouri, Ph.D., M.P.H.
Vice President Consulting, AI & Digital Policy, Real-World Research
Thursday, Dec. 4 from 11:20a.m. – 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.
Request a meeting
Are you interested in meeting with our experts at this event? Please fill out the form below, and we'll contact you with more details.