#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.

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