Overview
If you are a clinical data manager (CDM) or work with clinical data, do you enjoy the challenges of your daily work activities and all of the changes? Advanced technologies such as artificial intelligence are rapidly spreading. Although adoption of these technologies has been slow, digitalization and automation are now impacting clinical development workflow. At the same time, emerging use of eSource and digital devices also supports new clinical trial methodologies; so does the drive toward full implementation of standardized eData submission by 2020. All of these changes will ultimately result in complete end-to-end data automation, from planning to report and regulatory submission. In addition to the operational technology changes above, collaborations between academia and industry are increasing to address new advanced and translational medical technologies. The dynamic regulatory environment features recent revisions to various ICH guidelines such ICH E6(R2), E17, E9(R1), E8(R1), E19 and so on. 2019 is also the year we anticipate formal issuance of Pharmaceuticals and Medical Devices Law Amendment in Japan. At our 2019 CDM workshop, we discussed Are CDMs ready to ensure the data quality by QbD approach and what action must the CDMs take in order to extend the Risk-Based Approach? For 2020, our overall theme is Next Generation Data Managers– Let’s enjoy changes and adventures. We will discuss how CDMs can display leadership to manage sufficient data quality and enhance data reliability, reflecting the fact that the range of clinical trial data sources and types keep growing broader, for the next generation to follow. This workshop aims to improve the quality of clinical research and clinical data management activities and will provide numerous opportunities for networking and information exchange beyond industry, government, and academia.
Program Committee
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Mika Ogasawara • Quality Lead, Biometrics and Data Management
Pfizer R&D Japan, Japan -
Keisuke Utsumi • Head, Clinical Platforms & Sciences, Japan Development
GlaxoSmithKline K.K., Japan -
Kyoko Minamoto • Medical Technologist
National Cancer Center, Japan -
Yukikazu Hayashi • Exective director, Datascience Division, Associate Director,
A2 Healthcare Corporation, Japan -
Akimitsu Ikeura, MSc • Associate Director, Data Management Group, Biostatistics & Data Management Dept.
Daiichi Sankyo Co., Ltd., Japan -
Misato Kuwagaki, MS • Consultant, Clinical Laboratory and Data Sciences-eSource/Clinilcal Risk
Eli Lilly Japan K.K., Japan -
Takao Nakayama • Principal Inspector Office of Non-clinical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Tempei Miyaji, MSc • Project Assistant Professor, Department of Clinical Trial Data Management
The University of Tokyo Hosptial, Japan -
Koji Miyata • Manager, Data Management Group, Data Science Development
Astellas Pharma Inc., Japan -
Kotaro Sato • Senior Data Team Lead, Clinical Data Management, Data Sciences
IQVIA Services Japan K.K., Japan -
Naoko Yamamoto, MS •
Osaka University Hospital, Japan -
Yumiko Asami • Senior manager, Biostatistics
CSL Behring, Japan -
Motohide Nishi, MBA • Vice President, APAC Professional Services and Customer Care
Medidata Solutions K.K., Japan
