Conference: DIA Annual Meeting 2026
Date: June 14 - 18, 2026
Location: Philadelphia, PA
Where to hear Certara insights and expertise
Speaker: Liam O’Leary
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.
Key takeaways
- 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
This session is designed for regulatory affairs, regulatory operations, and regulatory/medical writing leaders seeking an implementable approach to using LLMs to modernize submissions—without compromising quality or compliance.
