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#527 IT: Certara Innovation Theater: LLM-Driven Submissions: From Data Preparation to eCTD
Tuesday June 16, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: Session

When introducing efficiencies to your regulatory workflow, it’s not simply a question of writing faster. Teams need to look up and down stream to accelerate data delivery, automate consistent first drafts and enable faster eCTD preparation. This session presents a practical, framework for regulatory submissions that connects data pipelines and GenAI-assisted authoring with eCTD publishing and lifecycle execution using Certara CoAuthor™ and Certara GlobalSubmit™. Attendees will learn how to design governance and workflows that make LLMs usable in regulated environments: establishing standardized templates and structured sections for repeatability; applying “human-in-the-loop” review checkpoints; and leveraging publishing-time validation to surface issues earlier—before they become last-minute blockers. The session will also highlight where LLM support delivers the most value (data aggregation, first-draft acceleration, consistency across sections, and faster content iteration) and how submission operations can translate better-authored content into smoother assembly, review, and health authority–compliant deliverables.

Learning Objectives

A reference architecture for LLM-driven regulatory authoring through eCTD submission execution; Practical controls for compliant GenAI use: structured content, standardized templates, and expert oversight; Methods to reduce cycle time and technical risk through robust validation and streamlined eCTD review workflows.

Chair

Certara

Speaker

Speaker
Liam O'Leary


Speakers
avatar for Certara

Certara

United States
avatar for Liam O'Leary

Liam O'Leary

Client Solutions Architect, Certara, United States
Liam O’Leary is a Client Solutions Architect at Certara.AI, applying GenAI to bridge science and software for life-sciences teams. He has delivered over 50 CoAuthor demonstrations for pharmaceutical and biotech companies, developed training and workflows for regulatory writers... Read More →
Tuesday June 16, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

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