19th DIA Japan Annual Meeting 2022

New “Quest for the future”~Moving Creativity and Innovation Forward in “New Normal”~

LS53 Application of RWD to Clinical Development: Discussion with Industry, Regulatory, and Academia Through Hypothetical Case Studies

Session Chair(s)

Takashi Moriya, PhD, MBA

• Product Owner (Senior Manager) - Healthcare
• Woven Alpha, Inc. (Woven Planet Holdings, Inc. group company), Japan

Speaker(s)

Yoshifumi Ukyo

• Manager, Statistics & Decision Sciences
• Janssen Pharmaceutical K.K., Japan

Junichi Asano, PhD

• Statistical Reviewer
• Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Shogo Nomura, PhD

• Statistician, Department of Biostatistics
• The University of Tokyo, Japan