From Manual Writing to Intelligent Drafting: Leveraging GenAI to Create Data Reviewer's Guides for Regulatory Submissions

About this session

Part of Session 5, Track C: Innovation/AI (Chair: Asif Karbhari, AstraZeneca).

The pharmaceutical industry faces increasing complexity and volume in regulatory submissions, driving the need for innovative documentation solutions. This paper will outline a framework utilizing Generative Artificial Intelligence (GenAI) to automate the creation of Data Reviewers Guides (DRGs), which provide crucial context for CDISC-compliant datasets submitted to regulatory agencies. GenAI employs Large Language Models (LLMs) with Retrieval-Augmented Generation (RAG) to generate content from reference documents, including study protocols, annotated case report forms, and statistical analysis plans. The paper demonstrates that GenAI streamlines the creation and maintenance of DRGs, significantly reducing manual workload while improving efficiency, consistency, and reliability for regulatory submissions such as FDA, PMDA, and NMPA.

Speakers

• SD

  Sirisha Davuluri

  Pfizer Inc.

  Speaker

• VC

  Valerie Cadorett

  Pfizer Inc.

  Speaker

• AK

  Asif Karbhari

  AstraZeneca

  Chair