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[SESSION 3] Data Managers’ Challenge (Education Session)
Session Chair(s)
Mika Ogasawara
Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Yasuharu Shibata, MSc
Head of Clinical Data Management, Cliinical Data Management
MSD K.K., Japan
Recent changes in clinical trial evaluation methodology, and the evolution of data collection devices and testing technologies, have increasingly made the definition of “source data” and data collection methods more complex. In addition, source data and data transportation are shifting to electric formats, and electronic data capture (EDC) is now common in investigator-initiated clinical trials. This session will discuss how to ensure reliability in data and data management practices from the pharmaceutical company, academia, and regulatory agency points of view. We hope this session will increase awareness of, and resolve questions raised by, daily data management practices.
Speaker(s)
Data Management for External Data
Hiroshi Kamayachi
MSD K.K., Japan
Document-Based Inspection by PMDA
Takashi Yoshitani, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Inspector, Office of Non-clinical and Clinical Compliance
Computerized System Validation of Clinical Data Management System with Electronic Data Capture (EDC) - System Validation Model Designing and Experience on Investigator-Initiated Registration Trial
Yumi Wakabayashi, MBA
Janssen Pharmaceutical K.K., Japan
Manager, Global Regulatory Policy & Intelligence, Asia Pacific
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