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SLS10 Status and Challenges of Regulatory Decision Making in Development Using Model Informed Drug Development
Session Chair(s)
So Miyoshi
Head of Clinical Pharmacology & Bioanalytics
Pfizer R&D Japan, Japan
Speaker(s)
Takayuki Imaeda, MPharm, MS
Pfizer R&D Japan, Japan
Head of Regulatory Sciences
Sanae Yasuda, PhD
Japan
Senior Director, Clinical Pharmacology, Medicine Development Center
Hiroki Sekiguchi, MS
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug III