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Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
Session Chair(s)
Angelika Joos, MPHARM
Executive Director, Science & Regulatory Policy
MSD, Belgium
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.
Learning Objective : 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.
Speaker(s)
Experience from global conduct of MRCTs
Aloka Chakravarty
Eli Lilly and Company, United States
VP, Clinical Data Insights and Advanced Analytics
Panelist
Paz Vellanki
FDA, United States
Associate Director, OND, CDER
PMDA perspective
Representative Invited
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
NMPA perspective
Representative Invited
National Medical Products Administration (NMPA), China
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