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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[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

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

Cases of Fraud/Misconduct in Clinical Studies

Ken Hayashi

AstraZeneca K.K., Japan

Associate Director, Quality Assurance Asia Pac

Yukiko  Enomoto

A Case Example of Misconduct

Yukiko Enomoto

Nihon University Itabashi Hospital, Japan

Clinical Research Center

Eri  Ikeda, MSN

Integrity of Clinical Trials in Japan - As a clinical on-site CRC

Eri Ikeda, MSN

Verlieben Inc., Japan

General Manager

Mami  Yabuki

Data Integrity at Pharmaceutical Manufacturing Site

Mami Yabuki

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Principal Inspector, Office of manufacturing/Quality and Compliance

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