Unpacking FDA’s New Draft Guidance on Uses of AI in the Biopharma Life Cycle

Unpacking FDA’s New Draft Guidance on Uses of AI in the Biopharma Life Cycle

• Wednesday, February 12, 2025 11:00 AM - 12:00 PM EST

Please join us for a webinar on "Unpacking FDA’s New Draft Guidance on Uses of AI in the Biopharma Life Cycle." FDA’s new draft guidance on AI in the biopharma life cycle addresses a broad set of AI use cases, ranging from drug development to post-market pharmacovigilance. FDA’s proposed AI assessment framework raises important considerations for sponsors and AI developers. We invite you to join members of Covington’s Digital Health and Food, Drug, and Device practices for a discussion of the draft guidance, outstanding questions about FDA’s approach, and related developments in the EU. We are excited to welcome Rebecca Nebel from PhRMA for this discussion.

CLE Credit will be offered for this event.

Event Details

Wednesday, February 12, 2025
11 a.m. - 12 p.m. EST
4 - 5 p.m. GMT

Log-in details will be provided upon registration.

Presenters

Joe Franklin
jfranklin@cov.com

Rebecca Nebel, PhD
PhRMA

Wade Ackerman
wackermanw@cov.com

Sarah Cowlishaw
scowlishaw@cov.com

This event is closed to the press.

CLE Credit: Covington & Burling LLP is certified by the State Bar of California and the New York State Continuing Legal Education Board as an Accredited Provider of Continuing Legal Education (CLE) credit. In accordance with jurisdictional requirements, pertinent participants may anticipate claiming a maximum of 1.0 CLE credit hours in NY (for both newly admitted and experienced attorneys) and CA upon verification of their attendance. Uniform Certificates of Attendance will be provided to all attendees should you wish to self-report in another jurisdiction.