Overview
Online Registration has been closed.
Onsite Registration will be available at the venue from 12:00-12:30 on Monday, February 19 and from 8:30-9:00 on Tuesday, February 20, 2018.
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.
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Program Committee
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Motohide Nishi, MBA Japan Site Leader & VP Professional Services
Medidata Solutions K.K., Japan -
Mika Ogasawara Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan -
Yukikazu Hayashi Assistant Head of Clinical Development
A2 Healthcare Corporation, Japan -
Akimitsu Ikeura, MSc Associate Director, Data Management Group, Biostatistics & Data Management Dept.
Daiichi Sankyo Co., Ltd., Japan -
Misato Kuwagaki, MS Associate Director, Data Sciences
Eli Lilly Japan K.K., Japan -
Kyoko Minamoto Medical Technologist
National Cancer Center, Japan -
Yukiko Nagata Director, Biometrics
ICON Clinical Research GK, Japan -
Hitoshi Ozawa, MPharm GCP Inspector, Office of Non-Clininical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Yasuharu Shibata, MSc Head of Clinical Data Management, Cliinical Data Management
MSD K.K., Japan -
Yumiko Asami Chapter Head of Clinical Data Science
Boehringer Ingelheim, Japan -
Yumi Sugiura, MRCP Global Clinical Operations, Global Data Management and Centralized Monitoring
Bristol-Myers Squibb K.K., Japan
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