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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
The University of Tokyo, Japan
Project Assistant Professor, Department of Clinical Trial Data Management
Utilization of Real World Data in GSK and Hurdle for Quality Management
Taizo Matsuki, PhD
GlaxoSmithKline K.K., Japan
Development & Medical Affairs Division
Our Expectation for Disease Registry Utilization in New Drug Development and Data Management
Yoshiharu Horie, PhD
AstraZeneca K.K., Japan
Director, Data Sceince, Medical Div.