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Enabling Faster Global Study Start-Up Through Regulatory Reliance and Harmonization
Session Chair(s)
Angelika Joos, MPHARM
Executive Director, Science & Regulatory Policy
MSD, Belgium
This session reviews how ICH E17/E5 harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory reliance, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.
Learning Objective : Analyze how regulatory harmonization and reliance 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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