Overview
Clinical Data Management (CDM) is entering an era of unprecedented transformation. With the advancement of digital transformation (DX) and artificial intelligence (AI), the methods of data collection, processing, and analysis are rapidly evolving, and the use of real-world data (RWD) is also expanding. In parallel, post-marketing surveillance (PMS) is increasingly demanding new approaches and responsibilities from CDM professionals, requiring more flexible and strategic responses than ever before. At the same time, regulatory frameworks such as the ICH-GCP are continuously evolving.
These changes bring both new opportunities and complex challenges. Yet, no matter how technologies advance, the fundamental mission of CDM—ensuring the reliability and integrity of clinical data—remains unchanged. In fact, it is precisely in times of change that this core value becomes even more critical.
This workshop will explore the future of CDM through the central question: “What core values must we preserve while embracing change?”
This workshop will address topics such as DX and AI, RWD, regulatory adaptation, PMS, quality management, and workforce development from both practical and strategic perspectives. Sessions will incorporate diverse perspectives from industry, government, and academia, with discussions expected to reflect both real-world experience and forward-looking insights. The workshop will also emphasize interactive engagement, including Q&A and panel discussions, to co-create practical knowledge that can be applied in daily practice.
How should we respond to the waves of change, and how can we enhance the value of CDM? We invite professionals, leaders, educators, regulators, and researchers from all sectors to join our forward-looking dialogue.
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Program Committee
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Yukiko Nagata Director, Biometrics
ICON Clinical Research GK, Japan -
Yusuke Inoue Data Scientist
Novartis Pharma K.K., Japan -
Kazumi Itayama Data Monitoring & Management
Pfizer R&D Japan, Japan -
Yuu Jincho, JD, MSc Manager, Data Practice Group, Biomedical Data Sciences Dept., RD Japan
GlaxoSmithKline K.K., Japan -
Megumi Kitayama Clinical Data Manager, Clinical Study Support Center
Wakayama Medical University Hospital, Japan -
Hiromi Nihei Clinical Data Manager, Data Management
Janssen Pharmaceutical K.K., Japan -
Miho Tabata Chief Reviewer, Office of generic Drugs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Fumiharu Tanaka, MPharm, RPh Manager, Clinical Operation
SHIONOGI & CO., LTD., Japan -
Hiroko Yaegashi Data Manager, Data Science I
A2 Healthcare Corporation, Japan -
Yoko Hattori Project Assistant Professor
Chiba University Hospital Clinical Research Center, Japan -
Akiko Kumagai Clinical Research Department 2, Development Business Division
Shionogi & Co. Ltd., Japan -
Sakura Yoshimasu Data Science Division
CMIC Co., Ltd., Japan -
Shoko Minagawa
Chugai Pharmaceutical Co., Ltd., Japan -
Hideto Minohara T-CReDO
University of Tsukuba Hospital, Japan -
Mitsuhiro Niimi, PhD Vice President & Managing Director, Japan
DIA, Japan
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