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The 23rd DIA Japan Annual Workshop for Clinical Data Management


Session-03: Data Quality Management by Risk-based approach

Session Chair(s)

Misato  Kuwagaki, MS

Misato Kuwagaki, MS

  • Consultant, Clinical Laboratory and Data Sciences-eSource/Clinilcal Risk
  • Eli Lilly Japan K.K., Japan
Takao  Nakayama

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

Introduction and Application of TransCelerate’s RBM Assets to Clinical Studies

Fumiharu Tanaka, MPharm, RPh

  • Clinical Reserch Dept.
  • Shionogi & Co., Ltd., Japan
Lisa  Ensign, PhD, MSc

Improving the Value of Queries in a RBQM World

Lisa Ensign, PhD, MSc

  • Principal Biostatistician
  • Medidata Solutions | Acorn AI, United States
Yumiko  Asami

Quality Management Process for Statistical Analyses Using CDISC Standards and Risk-Based Approach(Tentative)

Yumiko Asami

  • Senior Manager, Biostatistics
  • CSL Behring K.K., Japan