Back to Agenda
ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science
Session Chair(s)
Vada Perkins, MS
Vice President, Global Head of Regulatory Intelligence & Policy
Boehringer Ingelheim, United States
Explore how ICH M11, AI, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design, streamline submissions, and foster patient-centered innovation.
Learning Objective : Describe how ICH M11 and digital protocol standards enable seamless, patient-centric clinical trial design and regulatory submissions; Evaluate the impact of AI, cloud, and interoperable data platforms on accelerating regulatory review and improving patient access to innovation; Apply strategies for integrating patient experience data and digital tools to enhance trial inclusivity, data quality, and regulatory confidence.
Speaker(s)
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
European Medicines Agency, Netherlands
Panelist
Jimita Parekh, PHARMD
DNAnexus, United States
Managing Director
Panelist
Robert DiCicco, PHARMD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
Have an account?