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[Session 4]Never Too Late to Learn: General Topics for CDM (Education Session)
Session Chair(s)
Akimitsu Ikeura, MSc
Associate Director, Data Management Group, Biostatistics & Data Management Dept.
Daiichi Sankyo Co., Ltd., Japan
Hitoshi Ozawa, MPharm
GCP Inspector, Office of Non-Clininical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Nowadays in pharmaceutical industry CDM activities are highly specialized and divided, and each practice needs to follow standard procedures. Where did our standards come from? To explore such question, in this session we will provide the audience with some general topics which all clinical data managers should know such as ICH and GCDMP. It doesn’t matter what level you are in CDM experiences, you can use this opportunity to reset your knowledge.
Speaker(s)
ICH Update: Recent Topics of Clinical-related Guidelines
Masafumi Yokota, DVM, PhD
Daiichi Sankyo Co., Ltd., Japan
Senior Director
Update on ICH E2B(R3) in clinical trial
Hiroyuki Nishimoto, PhD
Kochi University, Japan
Specially Appointed Associate Professor
GCDMP as Training Metrics for Clinical Data Managers
Munenori Takata, MD, PhD
Tohoku University Hospital, Japan
Project Lecturer, Clinical Research Data Center