The program is in preparation.
More than a quarter of a century has passed since this workshop was first presented by DIA Japan, and as we convene for the 26th time, we are about to step into a new stage together. Since that first workshop, the clinical development environment has undergone rapid changes, and each time various methodologies and tools are developed, Clinical Data Manager (CDMs) have responded flexibly, proposing and disseminating changes for new data collection and management strategies and practices: For example, changing from paper to electronic data capture, developing more complex study designs, implementing risk-based monitoring, and more. In line with these trends, regulatory authorities have also issued and revised laws and guidelines, particularly in ICH-E6 and ICH-E8. International cooperation is also becoming more important in these areas. The COVID-19 pandemic further forced us to change our operations. While uncertainty about various changes that are constantly occurring remains, the CDM often acts as a hub for collaboration with other roles and stakeholders involved in the clinical development environment and responds by formulating the best action at the best time. In this way, CDMs have continued to adopt a wide variety of major changes that affect the methodology of clinical trials and clinical research, plus small changes and adjustments in their daily operations. Such adaptability may be one of the most important skills required for CDM. It is no exaggeration to say that CDMs manage not only clinical data but all related processes.
Recently, discussions on patient-focused drug development, secondary use of data, real-world data/evidence, etc. have become more active, and changes in the growing diversification of data sources, advances in technology, and the spread of de-centralized clinical trials (DCTs) are accelerating. This workshop will providing a place where we can mitigate concerns about such changes and share new expectations by introducing the latest data-related use cases, information from regulatory authorities, and related eff orts to address these changes. Our common purpose of protecting subjects and ensuring science and reliability through the “data,” may be the reason why such meaningful sharing and discussion are possible.
While inheriting the significance that has been cherished over the past quarter century, this 2023 workshop will firmly grasp the new wave of change, address new uncertainties and expectations, and take a strong new step forward through deep and lively discussions, that introduce new technologies with case studies, and respectfully considers opinions from industry, government, academia, and other perspectives.
• Clinical data managers
• Clinical research coordinators
• Clinical development professionals
• Information technology professionals
• QC/QA professionals
• Regulatory affairs professionals
• Post-marketing surveillance professionals
For those who would like to register in the Day3 Special Event
Session will be conducted in Japanese language only. Please apply from the dedicated site.
?Those who have registered for 26th Annual Workshop in Japan for Clinical Data Management can participate for free.
Who should attend?
Professionals involved in:
- Clinical data managers
- Clinical research coordinators
- Clinical development professionals
- Information technology professionals
- QC/QA professionals
- Regulatory affairs professionals
- Post-marketing surveillance professionals
Misato Kuwagaki, MS • Associate Director, Data Sciences
Eli Lilly Japan K.K., Japan
Yukikazu Hayashi • Exective Director, Buisiness Development Division
A2 Healthcare Corporation, Japan
Yumiko Asami • Principal Biostatistician, Biostatistics
CSL Behring, Japan
Michiko Ishida • Office of Non-clinicaland Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), 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
Juri Kato • Data manager
CHUGAI PHARMACEUTICAL CO., LTD., Japan
Yasuhiro Matsumoto • 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
Yuko Yamahara • Clinical Data Manager
Osaka University, Japan
Nanako Hamazaki • Tsukuba Clinical Research & Development Organization
University of Tsukuba, Japan
Tetsuya Sasaki, PhD • Chief of International Trial Management Section, Research Management Division,
National Cancer Center Hospital, Japan
Eri Sekine • Executive Vice President
CMIC Co., Ltd., Japan
Yoko Hattori • Project Assistant Professor
Chiba University Hospital Clinical Research Center, Japan
Akiko Kumagai • Associate Manager
JAPAN TOBACCO INC., Japan
Mika Ogasawara • Data Quality Lead, Biometrics and Data Management
Pfizer R&D Japan G.K., Japan
Please contact DIA Japan for further information.