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[V4-S3] Integrity of Clinical Trials in Japan - Get to the Root of the Problems and Prevent a Recurrence
Session Chair(s)
Shigeyuki Nakano, MD, PHD
Emeritus Professor, Oita University, Japan
Unfortunately, serious frauds have occurred which may unhinge trust in clinical trials in Japan. Accusing an individual or organization of fraud often looks like a “whack-a-mole” game. When a fraud occurs, is undetected, and is at last exposed, is there anything common among these various cases? This session will review recent frauds, try to identify what made people do so, and discuss what can be done to prevent recurrence of this misconduct.
Speaker(s)
Ken Hayashi
Associate Director, Quality Assurance Asia Pac, AstraZeneca K.K., Japan
Cases of Fraud/Misconduct in Clinical Studies
Yukiko Enomoto
Clinical Research Center , Nihon University Itabashi Hospital, Japan
A Case Example of Misconduct
Eri Ikeda, MSN
General Manager, Verlieben Inc., Japan
Integrity of Clinical Trials in Japan - As a clinical on-site CRC
Mami Yabuki
Principal Inspector, Office of manufacturing/Quality and Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Data Integrity at Pharmaceutical Manufacturing Site
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