Drawing on our speakers’ experience from FDA and the practical implementation of AI solutions in regulatory workflows, we level set on the difference between tools that enhance operational efficiency and those that require regulatory consideration and agency input. We discuss practical approaches to de-risk AI implementation while maintaining compliance with regulatory expectations. We focus on how to deliver measurable benefits through responsible AI adoption, illustrated through a real-world IND application case study.
Learning Objectives:
Understand which AI use cases fall within regulatory oversight versus those that remain outside agency purview in clinical research operations
Explore potential sponsor hesitancy around AI adoption and scale-up by focusing on de-risking implementation and use
Examine how AI can be responsibly applied in regulatory submissions, including a practical case study for IND processes
