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Session 1 : Which Data Should Be Collected in Clinical Trials?
Session Chair(s)
Keisuke Utsumi
Head, Development Global Medical, Japan Development Division
GlaxoSmithKline K.K., Japan
Mika Ogasawara
Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Speaker(s)
What Are Valuable Data for the clinical Evaluation of Novel Drugs? - From the regulator's view point -
Tetsuo Nakabayashi, MD, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Medical Informatics and Epidemiology
What Are Valuable Data for the Clinical Evaluation of Novel Drugs? Industry Pespective
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Perspectives for the Optimization of Data Collection
Yoji Nagai, MD, PHD
Foundation for Biomedical Research & Innovation, Japan
Deputy Director, Translational Research Informatics Center