A Regulatory Reviewer’s Perspective: Navigating AI, Risk and Compliance

Regulatory review is becoming more complex as scrutiny, evolving guidance, and new content formats reshape MLR workflows. In this video, MLR leader Robert Liebman and Iris R. Gibbs, a global regulatory expert, discuss the realities of regulatory review.

They explore what causes review slowdowns, including uncertainty around risk tolerance and cross-functional alignment. Iris also shares common issues that lead to rework, such as fair balance and the omission or inadequate presentation of risk information. The conversation looks at where AI could support regulatory review through claim validation, reference linking, labeling alignment, and risk flagging. At the same time, they discuss why human judgment remains essential when interpreting regulatory and political environments. The conversation offers a practical perspective on balancing technology, regulatory expertise, and the nuances of MLR review.