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[Session 3]ICH GCP Renovation E8 and Real World Data
Session Chair(s)
Yukikazu Hayashi
Assistant Head of Clinical Development, A2 Healthcare Corporation, Japan
Yukiko Nagata
Director, Biometrics, ICON Clinical Research GK, Japan
ICH GCP Renovation E8 and Real World Data
Speaker(s)
Introduction to Real World Data in Clinical Research
Tempei Miyaji, MSc
Project Assistant Professor, Department of Clinical Trial Data Management, The University of Tokyo, Japan
Utilization of Real World Data in GSK and Hurdle for Quality Management
Taizo Matsuki, PhD
Development & Medical Affairs Division, GlaxoSmithKline K.K., Japan
Our Expectation for Disease Registry Utilization in New Drug Development and Data Management
Yoshiharu Horie, PhD
Director, Data Sceince, Medical Div., AstraZeneca K.K., Japan