Advanced technology such as artificial intelligence, robotics, and natural language processing is penetrating and spreading healthcare product development, while use of eSource and digital devices supports digital data flow and suggests a new clinical trial methodology. Standardization to CDISC is envisioned by 2020 upon full implementation of eData submission, and, combined with the Common Protocol Template proposal, is also helping to lead the standardization and digitalization of end-to-end data flow.
Investigator-initiated trials and collaboration between academia and industry continue to increase as advanced and translational medical technologies such as regenerative and genetic medicine are more deeply incorporated into medical practice in Japan. The impact of these advanced technologies on approaches to drug and device development remains undetermined.
Are clinical data managers (CDMs) ready to ensure the quality of their data through Quality by Design (QbD) as ICH E6(R2) and E8 are being implemented and the “GCP Revolution” is openly discussed? What actions must CDMs take to extend the Risk-Based Approach from clinical trial design to clinical trial reporting and beyond, to post-market safety monitoring? Our overall theme Clinical Data Management in New Era: Enhance Data Reliability and Utilization to Adapt to Renovation reflects the fact the range of clinical trial types and data sources are rapidly expanding. We will collaboratively discuss how CDMs can enhance data reliability and utilization for various clinical trial designs and data sources throughout the drug and/or device product lifecycle, including post-market monitoring. It aims to improve the quality of both clinical research and clinical data management in Japan, and will provide numerous opportunities for networking and information exchange among industry, government, and academia.
Who should attend?
- Clinical data managers
- Clinical research coordinators
- Clinical development professionals
- Information technology professionals
- QC/QA professionals
- Regulatory affairs professionals
- Postmarketing surveillance professionals
Motohide Nishi, MBA • Vice President, Asia Pacific Technology
Medidata Solutions K.K., Japan
Mika Ogasawara • Manager, Japan Clinical Informatics & Innovation, Biometrics and Data Management
Pfizer Japan Inc., Japan
Yukikazu Hayashi • Division Manager, Development Strategy Division
A2 Healthcare Corporation, Japan
Akimitsu Ikeura, MSc • Manager, Data Management Group, Biostatistics & Data Management Dept.
Daiichi Sankyo Co., Ltd., Japan
Misato Kuwagaki, MS • Clinical Development Organization – Clinical Information & Process Automation
Eli Lilly Japan K.K., Japan
Kyoko Minamoto • Practical Research for Innovative cancer control Management Office (PRIMO)
National Cancer Center, Japan
Tempei Miyaji, MSc • Project Assistant Professor, Department of Clinical Trial Data Management
The University of Tokyo Hosptial, Japan
Yukiko Nagata • Associate Director, Clinical Data Management & Technology
Takeda PRA Development Center KK, Japan
Hitoshi Ozawa, MPharm • GCP Inspector, Office of Non-Clininical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yasuharu Shibata • Associate Director, Head of Clinical Data Mgt., Clinical Operations Area
MSD K.K., Japan
Yumiko Asami • Statistician, Manager, Electronic Data System Management Group, Biostatistics &
Daiichi Sankyo Co., Ltd., Japan
Yumi Sugiura, MRCP • Global Clinical Operations, Global Data Management and Centralized Monitoring
Bristol-Myers Squibb, Japan