2022 Japan Interchange Program
Presentations will be recorded for on-demand access. Post-event, attendees will also receive access to on-demand presentations from the 2022 Europe Interchange.
2022 Japan Interchange Program
9:00 - 10:30
Session 1: Welcome and Keynote Address
Akira Soma, J3C Chair, Oracle
Session 1 Recording
9:00-9:05
Housekeeping Information
Bernard Klinke, CDISC Virtual Experience Manager
9:05 - 9:30
Welcome Address & State of the CDISC Union
Dave Evans, CDISC President and CEO
9:30 - 10:30
ELSI (Ethical, Legal, and Social Implications) Aspects of Health Database in Japan
Ryuichi Yamamoto, MD. PhD. Chief Director, Medical Information System Development Center
10:30 - 11:00
Break
11:00 - 12:30
Session 2: CDISC Updates
Takuhiro Yamaguchi, J3C, Tohoku University
Session 2 Recording
11:00 - 11:30
State of CDISC Standards
Bess Leroy, CDISC
11:30 - 12:00
FHIR to CDISC: Mapping Real World Data Connections
Rebecca Baker, CDISC
12:00 - 12:30
DRAGON Project and the CDISC Observational Guide
Jon Neville and Kit Howard, CDISC
12:30 - 13:30
Lunch
13:30 - 14:50
Session 3: COVID-19 Related Topics
Hidetoshi Misawa, J3C, Pfizer
Session 3 Recording
13:30 - 14:00
Experience with Interim User Guide for COVID Studies & Guidance for Ongoing Studies
Arvind Sri Krishna Mani, Zifo RnD Solutions
14:00 - 14:50
Second Keynote Presentation: Use of SDTM and ADaM in the RECOVERY Trial of Treatments for COVID-19
Dr. Will Stevens, Ph.D, Oxford University
14:50 - 15:20
Break
15:20 - 16:20
Session 4: Implementation & Use Cases
Hideto Yokoi, J3C, Kagawa University
15:20 - 15:50
Slashing my first mapping, five years later!
Shizuko Takahara, Kanazawa University
15:50 - 16:20
SDTM Basics for ADaM Dataset Creation
Seiko Yamazaki and Chikaaki Nakao, Pinnacle 21
Session 5: Regulatory Presentations, Part I
Naoto Awaji, J3C, Chugai Pharmaceutical
Please See Above for Combined Recordings of Sessions 4 and 5
16:20 - 16:50
PMDA Presentation
Dr. Yuki Ando, Senior Scientist for Biostatistics; and Dr. Daisuke Iwata, Senior Reviewer, Pharmaceutical and Medical Devices Agency (PMDA)
16:50 - 17:30
EMA Presentation
Nick Halsey, Scientific Administrator; Seconded National Expert, Methodology Workstream, Data Analytics and Methods Task Force, European Medicines Agency (EMA)
16:50-17:30
EMA Presentation
Eftychia-Eirini Psarelli; Seconded National Expert, Methodology Workstream, Data Analytics and Methods Task Force, European Medicines Agency (EMA)
9:00 - 10:30
Session 6: Regulatory Presentations, Part II
Dr. Toshiki Saito, J3C Vice Chair, Nagoya Medical Center
Session 6 Recording
9:00 - 9:30
FDA CDER Update on CDISC SEND Submissions
Jesse Anderson, Lead Project Manager, Regulatory Review Services Team, Center for Drug Evaluation and Research (CDER), FDA
9:30 - 10:00
FDA CDER Presentation
Dr. Stephen Wilson, Senior Staff Fellow, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA
10:00 - 10:30
Regulatory Q&A Session
Dr. Stephen Wilson & Jesse Anderson, Center for Drug Evaluation and Research (CDER), FDA
10:30 - 11:00
Break
11:00 - 12:30
Session 7: Automation Topics
Hidemi Hasegawa, J3C Vice Chair, Boehringer Ingelheim
Session 7 Recording
11:30 - 12:00
Validation of Programs in Automated SDTM Datasets Creation
Kunihito Ebi, Fujitsu Limited
12:00 - 12:30
CDISC Analysis Results Standards - Approach and Development Update
Bess LeRoy, CDISC
11:00 - 11:30
Use of Artificial Intelligence(ML/NLU/NLP/NLG) in Regulatory(scientific) Documents Authoring
Farha Feroze, Symbiance Inc.
12:30 - 13:30
Lunch
13:30 - 14:30
Session 8: CDISC Standards
Hideaki Kosaka, J3C, EPS Corporation
Session 8 Recording
13:30 - 14:00
Upgrade/Downgrade to define.xml v2.0 for SDTM
Hajime Shimizu, Independent
14:00 - 14:30
Introduction to the CJUG CDASH Team
Yuko Tamura, Noriyuki Furuya, CJUG CDASH Team
14:30 - 15:00
Break
15:00 - 16:40
Session 9: Closing Plenary
Yoshiteru Chiba, J3C, UMIN
Session 9 Recording
15:00 - 15:30
SDTM Mapping for the T1Dexi Trial Using the T1D TAUG
John Owen, CDISC
15:30 - 16:00
CDISC CORE Status and Next Steps
Peter Van Reusel, CDISC
16:00 - 16:30
Q&A
Peter Van Reusel and John Owen, CDISC
16:30 - 16:40
Closing Remarks
Akira Soma, J3C Chair