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Keynote Session: The Center of “Excellence” - New Model for Clinical Study in Japan in the Risk-based Monitoring Era
Session Chair(s)
Suzuko Oikawa, RPh
Director, Clinical Research
Bristol-Myers Squibb, Japan
Kyoji Tamanoi
Senior Clinical Trial Manager, Clinical Trial Management
ICON Japan K.K., Japan
To continue improvement in clinical study operation it seems very important to understand the basic concept of Risk-based Monitoring when we pursue Operational Excellence. At this Keynote Session we will go back to the very basic point of ‘What is the risk?’ and ‘What kind of framework is required to manage the quality based on the risk?’. Then the concept of Risk-based Monitoring will be shared.
Speaker(s)
Risk-based Quality Management
Hiroe Tsubaki, DrSc, PhD
The Institute of Statistical Mathematics, Japan
Vice Director-General
Risk-Based Monitoring: From PMDA Point of View
Seiko Miyazaki, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of Standards and Guideline Development
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