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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)
Cases of Fraud/Misconduct in Clinical Studies
Ken Hayashi
AstraZeneca K.K., Japan
Associate Director, Quality Assurance Asia Pac
A Case Example of Misconduct
Yukiko Enomoto
Nihon University Itabashi Hospital, Japan
Clinical Research Center
Integrity of Clinical Trials in Japan - As a clinical on-site CRC
Eri Ikeda, MSN
Verlieben Inc., Japan
General Manager
Data Integrity at Pharmaceutical Manufacturing Site
Mami Yabuki
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Inspector, Office of manufacturing/Quality and Compliance