AI and the Regulatory Roadmap: Why Structured Submissions Win
In this second episode, Martin King explains how every submission is built around Context, Argument and Evidence, showing how regulators and Notified Bodies are moving toward data-centric, machine-readable submissions.
Join us for this second webinar in our latest series with Regulatory Affairs & Quality Assurance Consultant, Martin King.. AI is changing the rules of play for regulatory submissions. With FDA eSTAR now mandatory for most filings, sponsors must adopt structured formats that are machine-readable by design. The FDA is actively deploying AI tools to assist in reviewing structured data and has issued guidance on AI model credibility and context of use.