2023 Japan Interchange Program
Please click on sessions listed below to view all presenters and topics within each session.
9:00 - 10:45
Session 1: Opening Plenary
Akira Soma, J3C Chair, Oracle
9:00 - 9:15
Welcome Address: CDISC Strategy and the Future
Dave Evans, CDISC President and CEO
9:15 - 9:45
ICH M11 Clinical Protocol Template
Dr. Ron Fitzmartin, FDA-CBER
9:45 - 10:15
Advancing Pre-Market Safety Analytics
Dr. Veronica Pei, FDA-CDER
10:15 - 10:45
FDA-CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chrissie Cai, FDA-CTP; and Peter Van Reusel, CDISC
10:45 - 11:15
Morning Break
11:15 - 12:45
Session 2: Second Plenary
Dr. Hideto Yokoi, Kagawa University Hospital
11:15 - 11:45
Opening Keynote Presentation
Dr. Wenjun Bao, CDISC Board of Directors, JMP Clinical
11:45 - 12:15
PMDA Presentation
Dr. Yuki Ando, PMDA
12:15 - 12:45
CDISC Standards Update (ARS, DDF, TIG, Foundational Standards, TMF)
Peter Van Reusel, CDISC
12:45 - 14:15
Lunch Break
14:15 - 15:30
Session 3: Academic Research
Yoshiteru Chiba, University Hospital Medical Information Network
14:15 - 14:40
SDTM Modeling in Investigator-Initiated Clinical Trials for Solid Tumors: A Case Study by CJUG-SDTM
Matsuo Yamamoto, National Hospital Organization Nagoya Medical Center
14:40 - 15:05
Why is CDASH Needed to Map eCRF Data to SDTM?
Dr. Anna Tsutsui, Toho University
15:05 - 15:30
Team Activity Progression of “Beginner’s Initiative Mock Clinical Trial ~ New Duck team~” in CJUG SDTM Subteam
Megumi Kitayama, Wakayama Medical University Hospital
15:30 - 16:00
Afternoon Break
16:00 - 17:50
Session 4: Real World Data & Regulatory Presentations/Perspectives
Hidetoshi Misawa, Pfizer
16:00 - 16:25
Lessons Learned from Sharing Clinical Trial Data Using Vivli
Azusa Tsukida, Vivli
16:25 - 16:50
CDISC RWD activities (DHTs, NIAID workshop on Obs Data, eCRFs, RWD-SDTMetc.)
Rhonda Facile, CDISC
16:50 - 17:20
PMDA and RWD
Dr. Daisuke Iwata, PMDA
17:20 - 17:50
EMA Presentation
Dr. Marcia Rueckbeil, EMA
9:00 - 10:45
Session 5: Data Science
Naoto Awaji, Chugai
9:00 - 9:30
Update on CDISC DS Activities (CDISC, Dataset JSON, Conformance Rules and CORE Engine)
Dr. Sam Hume, CDISC
9:30 - 9:55
Integrated Process of aCRF with Dual Bookmarking and TOC for SDTM-MSG-V2.0
Xinran Luo, Everest Clinical Research
9:55 - 10:20
Blockchain Technology for Clinical Data Sharing
Kentaro Arai, Novartis
10:20 - 10:45
PHUSE/CDISC Collaboration
Yoshiko Kitagawa, ONO Pharmaceutical Co., Ltd.
10:45 - 11:15
Morning Break
11:15 - 12:30
Session 6: Standards Implementation and Driving Automation
Daisuke Hisada, GlaxoSmithKline K.K.
11:15 - 11:40
Automating SDTM and ADaM Creation in Clinical Trials
Rie Ichihashi, Sanofi
11:40 - 12:05
Populating DDF Study Definitions Repository from study protocol using AI
Kunihito Ebi, Fujitsu Limited
12:30 - 14:00
Lunch Break
14:00 - 15:40
Session 7: Global Regulatory Submissions
Takako Nozaki, Gilead Sciences
14:00 - 14:25
Our Guide On Creating A Successful BIMO Data Package
Arvind Sri Krishna, Zifo Scientific Informatics
14:25 - 14:50
Using R to Generate Analysis Results Metadata (ARM)
Aik Hoe Seah, Cytel
14:50 - 15:15
Our Experience and Learnings from Doing Multiple Submissions
Jeba Kumar, Pfizer
15:40 - 16:10
Afternoon Break
16:10 - 17:30
Session 8: Closing Plenary
Akira Soma, Oracle
16:10 - 16:40
Closing Keynote Presentation: CDISC in the World of Standards
Dr. Michio Kimura, Kawasaki Medical University, Dept. of Medical Informatics
16:40 - 17:25
Closing Panel
- Akira Soma, Oracle
- Dr. Wenjun Bao, JMP Clinical
- Dr. Yuki Ando, PMDA
- Dr. Sam Hume, CDISC
- Rhonda Facile, CDISC
- Peter Van Reusel, CDISC
- Additional panelists invited
17:25 - 17:30
Closing Remarks
Akira Soma, Oracle