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Session-03: Data Quality Management by Risk-based approach
Session Chair(s)
Misato Kuwagaki, MS
Associate Director, Data Sciences
Eli Lilly Japan K.K., Japan
![Takao Nakayama](/_Images/member/Generic_Image_Missing-Profile.jpg)
Takao Nakayama
Principal Inspector Office of Non-clinical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Introduction and Application of TransCelerate’s RBM Assets to Clinical Studies
Speaker(s)
![Fumiharu Tanaka, MPharm, RPh](/_Images/member/Generic_Image_Missing-Profile.jpg)
Introduction and Application of TransCelerate’s RBM Assets to Clinical Studies
Fumiharu Tanaka, MPharm, RPh
SHIONOGI & CO., LTD., Japan
Manager, Clinical Operation
Improving the Value of Queries in a RBQM World
Lisa Ensign, PhD, MSc
Medidata, a Dassault Systemes Company, United States
VP, Data Science
![Yumiko Asami](/_Images/member/Generic_Image_Missing-Profile.jpg)
Quality Management Process for Statistical Analyses Using CDISC Standards and Risk-Based Approach(Tentative)
Yumiko Asami
Boehringer Ingelheim, Japan
Chapter Head of Clinical Data Science
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