#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
Monday, June 15, 2026 4:00 PM to 5:00 PM · 1 hr. (America/New_York)
108B
02: ClinicalTrialOps-Innovation08: RegPolicy-Strategy-GlobalCollaboration
Information
This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory collaboration, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Global Alignment in Practice
Learning Objectives
Analyze how regulatory harmonization and collaboration accelerate global study start-up; Differentiate key principles of ICH E17, E5, and regional oncology MRCT guidelines; Summarize strategies to navigate regional regulatory differences and enable global studies.
Speakers
Angelika Joos
Executive Director, Science & Regulatory PolicyMSD
Yoko Aoi
Coordination Director - Office of Review ManagementPharmaceuticals and Medical Devices Agency (PMDA)AC
Aloka Chakravarty
VP, Clinical Data Insights and Advanced AnalyticsEli Lilly and CompanyPV
Paz Vellanki
Associate Director, OND, CDERFDA
Sarah White
Executive DirectorMRCT Center