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ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science
Session Chair(s)
Vada Perkins, DRSC, MSC
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.
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