Leverage AI To Accomplish the Impossible: An Inspection Ready TMF

About this session

Part of Session 5, Track D: Inspection Readiness (Chair: Steph Viscomi, Kymera Therapeutics).

Preparing TMF for regulatory inspection under aggressive timelines is often viewed as an impossible mission,particularly when documentation gaps, quality inconsistencies, and resource constraints collide. This session explores how a risk based approach combined with practical applications of Artificial Intelligence (AI) can transform TMF readiness from a reactive scramble into a focused, inspection ready outcome.
This session is designed for inspection readiness teams seeking measurable, sustainable improvements in TMF readiness. Attendees will learn how AI can be leveraged to rapidly assess TMF completeness, identify high risk content, prioritize remediation efforts, and support quality oversight without compromising quality expectations. The presentation will demonstrate how AI enabled tools can assist with completeness assessments, trend detection, and inspection narrative preparation,complimenting human efforts rather than replacing it.
With the right strategy and controls in place, Mission Impossible is no longer impossible ,it is achievable, in part, through thoughtful and strategic use of AI.

Speakers

• MM

  Marion Mays

  Jerion Consulting

  Speaker

• CS

  Chad Scribner

  Epista

  Speaker