2022 Japan Interchange Presentation Archive
You have reached the archived program from the 2022 Japan Virtual Interchange.
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Session 1: Welcome and Keynote Address
Akira Soma, J3C Chair, Oracle
Session 1 Recording
Housekeeping Information
Bernard Klinke, CDISC Virtual Experience Manager
Welcome Address & State of the CDISC Union
Dave Evans, CDISC President and CEO
Presentation Files
Document
ELSI (Ethical, Legal, and Social Implications) Aspects of Health Database in Japan
Ryuichi Yamamoto, MD. PhD. Chief Director, Medical Information System Development Center
Presentation Files
Document
Session 2: CDISC Updates
Takuhiro Yamaguchi, J3C, Tohoku University
Session 2 Recording
State of CDISC Standards
Bess Leroy, CDISC
Presentation Files
Document
FHIR to CDISC: Mapping Real World Data Connections
Rebecca Baker, CDISC
Presentation Files
Document
DRAGON Project and the CDISC Observational Guide
Jon Neville and Kit Howard, CDISC
Presentation Files
Document
Session 3: COVID-19 Related Topics
Hidetoshi Misawa, J3C, Pfizer
Session 3 Recording
Experience with Interim User Guide for COVID Studies & Guidance for Ongoing Studies
Arvind Sri Krishna Mani, Zifo RnD Solutions
Presentation Files
Document
Second Keynote Presentation: Use of SDTM and ADaM in the RECOVERY Trial of Treatments for COVID-19
Dr. Will Stevens, Ph.D, Oxford University
Presentation Files
Document
Session 4: Implementation & Use Cases
Hideto Yokoi, J3C, Kagawa University
Slashing my first mapping, five years later!
Shizuko Takahara, Kanazawa University
Presentation Files
Document
SDTM Basics for ADaM Dataset Creation
Seiko Yamazaki and Chikaaki Nakao, Pinnacle 21
Presentation Files
Session 5: Regulatory Presentations, Part I
Naoto Awaji, J3C, Chugai Pharmaceutical
Please See Above for Combined Recordings of Sessions 4 and 5
PMDA Presentation
Dr. Yuki Ando, Senior Scientist for Biostatistics; and Dr. Daisuke Iwata, Senior Reviewer, Pharmaceutical and Medical Devices Agency (PMDA)
Presentation Files
EMA Presentation
Nick Halsey, Scientific Administrator; Seconded National Expert, Methodology Workstream, Data Analytics and Methods Task Force, European Medicines Agency (EMA)
Presentation Files
Document
EMA Presentation
Eftychia-Eirini Psarelli; Seconded National Expert, Methodology Workstream, Data Analytics and Methods Task Force, European Medicines Agency (EMA)
Presentation Files
Session 6: Regulatory Presentations, Part II
Dr. Toshiki Saito, J3C Vice Chair, Nagoya Medical Center
Session 6 Recording
FDA CDER Update on CDISC SEND Submissions
Jesse Anderson, Lead Project Manager, Regulatory Review Services Team, Center for Drug Evaluation and Research (CDER), FDA
Presentation Files
Document
FDA CDER Presentation
Dr. Stephen Wilson, Senior Staff Fellow, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA
Presentation Files
Document
Regulatory Q&A Session
Dr. Stephen Wilson & Jesse Anderson, Center for Drug Evaluation and Research (CDER), FDA
Session 7: Automation Topics
Hidemi Hasegawa, J3C Vice Chair, Boehringer Ingelheim
Session 7 Recording
Validation of Programs in Automated SDTM Datasets Creation
Kunihito Ebi, Fujitsu Limited
Presentation Files
Document
CDISC Analysis Results Standards - Approach and Development Update
Bess LeRoy, CDISC
Presentation Files
Document
Use of Artificial Intelligence(ML/NLU/NLP/NLG) in Regulatory(scientific) Documents Authoring
Farha Feroze, Symbiance Inc.
Presentation Files
Document
Session 8: CDISC Standards
Hideaki Kosaka, J3C, EPS Corporation
Session 8 Recording
Upgrade/Downgrade to define.xml v2.0 for SDTM
Hajime Shimizu, Independent
Presentation Files
Document
Introduction to the CJUG CDASH Team
Yuko Tamura, Noriyuki Furuya, CJUG CDASH Team
Presentation Files
Break
Session 9: Closing Plenary
Yoshiteru Chiba, J3C, UMIN
Session 9 Recording
SDTM Mapping for the T1Dexi Trial Using the T1D TAUG
John Owen, CDISC
Presentation Files
Document
CDISC CORE Status and Next Steps
Peter Van Reusel, CDISC
Presentation Files
Document
Q&A
Peter Van Reusel and John Owen, CDISC
Closing Remarks
Akira Soma, J3C Chair
Presentation Files