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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
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)
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
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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