Director - Regulatory Services and Medical Affairs Certara
Generative AI is transforming the field of regulatory writing, but its capabilities go far beyond clinical study reports (CSRs). To truly maximize its value, teams must explore opportunities to automate processes across the entire submission dossier. This session with Certara will explore innovative strategies to harness generative AI for a range of applications, including pre-clinical module 3 documents, pharmacokinetic (PK) study reports, periodic benefit-risk evaluation reports (PBRERs), and more.
Learning Objectives:
Understand how generative AI can be applied creatively to perform use cases beyond just text creation.
Identify key benefits and challenges of integrating generative AI into regulatory writing workflows.
Learn practical strategies for automating diverse submission dossier components, including pre-clinical and post-market documents.
