2026 CDISC x SCDM Japan Interchange Program
10:00 - 12:00
Session 1: Opening Plenary
Akira Soma, J3C Chair, Oracle
10:00 - 10:05
Opening Remarks
Akira Soma, J3C Chair, Oracle
10:05 - 12:00
Chatting Session
Yasuharu Shibata, JSC, MSD; and Megumi Kitayama, J3C, Nagoya Medical Center
Join our interactive chatting session, where participants will discuss SCDM Competencies and CDISC-related topics in small groups.
Topics may include RPA/AI adoption, Risk-Based Approaches, open-source solutions, and other emerging trends in clinical data management/CDISC.
12:00 - 13:30
Lunch Break
13:30 - 15:00
Session 2
Akira Soma, J3C Chair, Oracle; and Yukikazu Hayashi, JSC Chair, A2 Healthcare
13:30 - 15:00
Keynote Presentation
Dr. Takuhiro Yamaguchi, Japan Society of Clinical Trials and Research, Past JSC Chair, Past J3C Member; and Dr. Yuki Ando, PMDA, CDISC Board of Director, J3C, JSC
15:00 - 15:30
Coffee Break
15:30 - 16:30
Session 3
Noriyuki Shibayama, JSC, Johnson & Johnson; and Hideaki Kosaka, J3C, EPS
15:30 - 16:30
Building the Digital Foundation for Clinical Research Innovation: The Power of the CDISC–SCDM Partnership
Ward Lemaire, SCDM Chair, Johnson & Johnson; Peter Van Reusel, CSO, CDISC; and Jonathan Chainey, Former Chair of the CDISC Advisory Council, Roche
16:30 - 16:40
Short Break
16:40 - 17:40
Session 4
Dr. Yuki Ando, J3C, JSC, PMDA
16:40 - 17:40
Regulatory Update: EMA, PMDA
17:40 - 20:00
Reception Party at Café
8:30 - 10:00
Session 5
Yoshiko Kitagawa, J3C, Ono Pharmaceuticals
8:30 - 10:00
FDA Related Topics
10:00 - 10:30
Coffee Break
10:30 - 12:00
Session 6, Track A
Dr. Munenori Takata, JSC, Tohoku University Hospital
10:30 - 12:00
From Global Trends in Clinical Data Management to Career Ladders: A Roadmap for Clinical Data Professionals
10:30 - 12:00
Session 6, Track B
Dr. Hideto Yokoi, J3C, Kagawa University Hospital
10:30 - 12:00
CDISC in Academia
12:00 - 13:30
Lunch Break
13:30 - 15:00
Session 7, Track A
Dr. Satoru Fukimbara, JSC, Ono Pharmaceutical
13:30 - 15:00
The Evolution of Risk-Based Approaches in the Era of GCP Renovation and Clinical Trial Transformation
13:30 - 15:00
Session 7, Track B
Hidetoshi Misawa, J3C, Pfizer
13:30 - 15:00
DDF Related Topics
15:00 - 15:30
Coffee Break
15:30 - 17:00
Session 8, Track A
Dr. Hiroshi Ohtsu, JSC, Juntendo University
15:30 - 17:00
Innovation AI for Data Science
15:30 - 17:00
Session 8, Track B
Akari Kamitani, J3C, Shionogi
15:30 - 17:00
Innovation AI with CDISC
17:00 - 17:10
Short Break
17:10 - 17:50
Session 9
Yoshiteru Chiba, J3C, UMIN Center
17:10 - 17:40
Closing Keynote: Future for Clinical Research
Reza Rostami, JSC, Duke Clinical Research Institute
17:40 - 17:50
Closing Remarks