Program of events is subject to change.

2022 Japan Interchange Program

Presentations will be recorded for on-demand access
All times shown are in Japan Time
Simultaneous Japanese-English Translation Available | 日本語英語 同時通訳あり

Session 1: Welcome and Keynote Address

9:00 - 10:30
Akira Soma, J3C Chair, Oracle

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

First Keynote Presentation

Ryuichi Yamamoto, MD. PhD. Chief Director, Medical Information System Development Center.

Break

10:30 - 11:00

Session 2: CDISC Updates

11:00 - 12:30
Takuhiro Yamaguchi, J3C, Tohoku University

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

Lunch

12:30 - 13:30

Session 3: COVID-19 Related Topics

13:30 - 14:50
Hidetoshi Misawa, J3C, Pfizer

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

Break

14:50 - 15:20

Session 4: Implementation & Use Cases

15:20 - 16:20
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

16:20 - 16:50

PMDA Presentation

Dr. Yuki Ando, Senior Scientist for Biostatistics; and Daisuke Iwata, Senior Reviewer, Pharmaceutical and Medical Devices Agency (PMDA)

16:50 - 17:30

EMA Presentation

Nick Halsey, Scientific Administrator; and Eftychia-Eirini Psarelli, Seconded National Expert, Methodology Workstream, Data Analytics and Methods Task Force, European Medicines Agency (EMA)

Session 6: Regulatory Presentations, Part II

9:00 - 10:30
Dr. Toshiki Saito, J3C Vice Chair, Nagoya Medical Center

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

Break

10:30 - 11:00

Session 7: Automation Topics

11:00 - 12:30
Hidemi Hasegawa, J3C Vice Chair, Boehringer Ingelheim

11:00 - 11:30

Use of Artificial Intelligence(ML/NLU/NLP/NLG) in Regulatory(scientific) Documents Authoring

Farha Feroze, Symbiance Inc.

11:30 - 12:00

Validation of Programs in Automated SDTM Datasets Creation

Kunihito Ebi, Fujitsu Limited

12:00 - 12:30

An Efficient Approach to Automatically Trace Back Clinical Data from Analysis to Source

Haiqiang Luo, Hengrui Pharma

Lunch

12:30 - 13:30

Session 8: CDISC Standards

13:30 - 14:30
Hideaki Kosaka, J3C, EPS Corporation

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

Break

14:30 - 15:00

Session 9: Closing Plenary

15:00 - 16:40
Yoshiteru Chiba, J3C, UMIN

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