Advanced and translational medical technology, such as regenerative medicine and genetic medicine, are already being incorporated into our medical practices, and artificial intelligence and medical robots are developing and spreading. At the same time, the use of eSource data, genomics data, and real-world data is accelerating to provide important health information about patients. Under such circumstances, the Clinical Data Manager (CDM) not only manages the data of conventional clinical trials and clinical research, but is also required to make a change toward the next era. By learning and applying new creative ideas, we will determine the direction the CDM should evolve.
Are CDMs ready to break away from "error-free faith" in securing data quality along with the application of updated ICH E6 and E9? The CDM must take the initiative and appropriate actions to change in order to extend the Risk-Based Approach, which began from clinical monitoring, from clinical trials, and furthermore to the safety monitoring activity after marketing.
The overall theme is “New Paradigm - Better Medical Care and a Healthier World Made Possible by CDM”, reflecting the growth of this workshop and how it continually leads innovation in the field. We will discuss how the CDM can contribute to new change and value creation throughout health care development such as clinical development, postmarketing, medical treatment, disease prevention, and more.
This workshop is aimed at improving 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.
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 • Associate Consultant, Process&Technology, Global Data Delivery, Data Sci.&Sol.
Eli Lilly Japan K.K., Japan
Kyoko Minamoto • Clinical Research Support Office
National Cancer Center Hospital East, Japan
Yukiko Nagata • Associate Director, Clinical Data Management & Technology
Takeda PRA Development Center KK, Japan
Hitoshi Ozawa • 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
Daiichi Sankyo Co., Ltd., Japan
Yumi Sugiura, MRCP • Senior Central Monitor, Global Data Strategies and Solutions
Bristol-Myers Squibb K.K., Japan