2021 Japan Academic Workshop

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
15:05-15:25 Break --
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