Walter E. Washington Convention Center

Jun 15, 2025 7:00 AM - Jun 19, 2025 3:00 PM

801 Allen Y. Lew Place, NW, Washington, DC 20001-3614, USA

DIA 2025 Global Annual Meeting

Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier

Session Chair(s)

Representative Invited

Representative Invited

United States

Generative AI adoption within the regulatory writing field has made tremendous progress over the last year. However, to maximize ROI, teams need to identify ways to expand automation beyond traditional benchmarks and clinical study report (CSR) applications. In this session Certara will share practical approaches for leveraging generative AI across the submission dossier from pre-clinical module 3 documents to PK study reports to PBRERs and more.

Speaker(s)

Nick  Brown

Speaker

Nick Brown

Certara, United States

Director, Global Portfolio Leader, Certara.AI

David  Meats

Speaker

David Meats

Certara, United States

Director, Regulatory Services & Medical Affairs Management

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