Talk AI & Cognitive Tech track
Generative AI and Clinical Development: Exploring the Frontier of AI Governance
Tue, Sep 30, 2025 · 9:00–10:00 AM EDT Room 339+340, Baltimore Convention Center
About this session
Session chaired by Munenori Takata
Description:
This session examines the implementation of generative AI in clinical development and underscores the importance of AI governance. As global regulatory bodies explore the balance between promoting and regulating AI use, particularly in clinical development, this discussion is timely and necessary. Generative AI applications in this field can be broadly categorized into diagnostic uses like medical image analysis and programmatic medical devices, as well as operational efficiency improvements in clinical data management and analysis. However, clear guidelines for governance are currently lacking.
To foster the use of generative AI in clinical development, it is essential first to organize and understand AI governance regulations across different regions. Building on this understanding, we propose the development of universally applicable AI policy templates for organizations involved in clinical development.
During this session, we will present an overview of AI governance regulations by region and introduce AI policy templates that we have developed. Additionally, we will share results of effectiveness studies conducted within Japanese clinical development organizations and specific CDM communities. The goal of this session is to enhance participants' understanding of effective and responsible use of generative AI in clinical development.
