Friday, 05 November; 13:00pm – 17:30pm Japan Standard Time
This half-day workshop will have presentations on how CDISC can be utilized by academia in Japan. PMDA and AMED will present regulatory expectations and helpful approaches for implementing CDISC standards. Researchers will share the challenges, value, use cases and review processes of using CDISC standards.
Please note: this workshop will be held in Japanese.
Academic-focused presentations by thought leaders from...
- National Hospital Organization (NHO) Nagoya Medical Center
- University Hospital Medical Information Network (UMIN) Center
- Sapporo Medical University
- Tohoku University Graduate School of Medicine
- Kanazawa University
Program is preliminary and subject to change.
|13:00-13:05||Opening Remarks||Akira Soma, J3C Chair|
|13:05-13:35||Use of CDISC Standardized Observational Data to Support Regulatory Decisions||TBD|
|13:35-13:55||TBD||Kunihito Ebi, Fujitsu|
|13:55-14:25||AMED Project - Research on Inter-Institutional Collaboration for Promoting the Use of CDISC Standards in Academia||Dr. Toshiki Saito, Director, Department of Regenerative Medicine, Clinical Research Center, National Hospital Organization Nagoya Medical Center|
|14:25-14:45||Challenges with Promoting the Use of CDISC Standards in Academic Organizations - Case of Clinical Research Data Center at Tohoku University Hospital||Dr. Takuhiro Yamaguchi, Professor at Division of Biostatistics, Tohoku University Graduate School of Medicine and Director of Clinical Research Data Center, Tohoku University Hospital|
|14:45-15:05||A Case of Data Management in Conformity with CDISC/SDTM in Academia - Kanazawa University||Dr. Shizuko Takahara, Assistant Professor, Innovative Clinical Research Center, Kanazawa University|
|15:25-15:45||Some TIPS for Collaboration with Academia Based on an Experience of Assessing Convertability of ISS Study Data to CDISC-compliant Data Format||Yumiko Kawabata, Biostatistics Group2, Biostatistics & Programming, Clinical Science and Operation, R&D, Sanofi KK|
|15:45-16:05||CRO Support for Investigator-Initiated Clinical Trials||Takahiro Tano, Japan CRO Association|
|16:05-16:25||CDISC Education in Japan||Yoshiteru Chiba, CDISC Japan Liaison, CDISC|
|16:25-16:45||Tips for Obtaining Useful Information to Aid in Implementing CDISC Standards||TBD|
|16:45-17:05||Challenges of Applying CDISC Standards to Observational Study Data Obtained from a Large Claims Database in Japan||Dr. Shiro Hinotsu, Professor, Department of Biostatistics, Sapporo Medical University|
|17:05-17:20||CDISC Strategy to Support Academic Research||TBD|
|17:20-17:30||Closing Remarks||Dr. Takahiro Kuchi, Director, UMIN Center, the University of Tokyo Hospital Professor, Department of Health Communication|