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Session 4: Open a New Epoch of the Standardization
Session Chair(s)
Yukiko Nagata
Director, Biometrics
ICON Clinical Research GK, Japan
Kenji Nagaya
Project Manager, Clinical Research Center
Nagoya Medical Center, Japan
The “Standardization” of business processes, IT systems, or clinical data is a very useful “tool” in order to create new drugs innovatively in our clinical data management field. In this session, three speakers which have been struggling to open the door to a new era will introduce you their efforts and approaches to manipulate the “tool” freely. And then, we would like to discuss with you how we stand up and effort to this new era, and what we should do to establish.
Speaker(s)
Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program
Bill Gluck, PhD, MS
Durham Technical Community College, United States
Program Director, Clinical Trial Research Programs
“CDISC SHARE” based Standards Development Approach - Through CDISC Asthma Therapeutic Area Standards Development
Miho Hashio, MPharm
GlaxoSmithKline K.K., Japan
Director, Data Standards, Clinical Data Operations Pharma R&D
Experience in Preparing Clinical Data Submissions to the FDA
Satoru Tsuchiya, MSc
JPMA (Japan Pharmaceutical Manufacturers Association)/Sumitomo Pharma, Co., Ltd., Japan
Senior Director, Global Data Design Office
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