Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Description: As regulatory authorities begin using AI to support submission review—screening documents, extracting structured data, and flagging inconsistencies—the game is changing. Submissions aren’t just read by humans anymore. And as AI tools are increasingly used by sponsor teams to draft parts of NDAs/ INDs/ BLAs, the submission process is evolving on both ends.
This interactive solution circle invites participants to discuss the practical implications of this “dual AI” dynamic—where machines may be involved in both creating and reviewing content. What does this mean for how regulatory professionals draft submissions, structure arguments, and trace data back to source?
We’ll explore: - What might change if regulators start reading with AI before humans? - How does this influence the way you write and QC your submissions? - What skills and frameworks do regulatory professionals need to stay in control as AI becomes embedded in both sponsor and agency workflows?
Attendees will leave with peer perspectives and actionable ideas for how they can adapt their submission planning, content review, and strategic role in an increasingly AI-driven regulatory environment.
Learning Objectives:
Upon completion, participants will have a better understanding of how the use of AI by health authorities may influence the structure, clarity, and traceability expected in regulatory submissions.
Upon completion, participants will be better prepared for a future of “one-click dossiers” and can reimagine current submission workflows.
