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LS53 Application of RWD to Clinical Development: Discussion with Industry, Regulatory, and Academia Through Hypothetical Case Studies
Session Chair(s)
Takashi Moriya, PHD, MBA
Research Fellow
Keio University, KBS (Keio Business School) Graduate School, Japan
Speaker(s)
Yoshifumi Ukyo
Janssen Pharmaceutical K.K., Japan
Associate Director, Statistics & Decision Sciences
Junichi Asano, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Senior Biostatistician, Office of New Drug IV
Shogo Nomura, PHD
The University of Tokyo, Japan
Statistician, Department of Biostatistics