AI and the Regulatory Roadmap: Why Structured Submissions Win

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. Certain elements, like the Software Bill of Materials (SBOM), are already required in machine-readable formats. 

Meanwhile, the EU AI Act, effective August 2024, introduces a risk-based framework that mandates dual conformity for high-risk AI-enabled medical devices. Notified Bodies are shifting toward data-centric assessments, and the days of static, document-based submissions are numbered. 

While many submissions still get rejected for incompleteness, a clear signal that legacy practices are no longer sustainable.  Structured based content tools can help sponsors ensure that their submission document is complete. 

In this 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. You’ll see how regulators and Notified Bodies are converging on machine-readable, traceable documentation, and how structured content helps you stay current. 

You’ll learn: 

• What the EU AI Act and FDA initiatives mean for your submissions. 
• How structured content makes files machine-ready without losing the human narrative. 
• Why a conscious use of the Context-Argument-Evidence model improves traceability and review speed. 
• Three practical experiments to start now: a PDF pain audit, a micro-pilot component, and a submission storyboard. 

Missed the first webinar in the series? Catch-up on-demand today.

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