2026 Korea CDISC Day Program
10:00 - 10:20
Opening Remarks & Welcome Address
Dr. Byungkwan Park, K3C Chair; and Dr. Kyung-Sang Yu, Seoul National University Hospital CTC
10:20 - 12:00
Session 1: Global Regulatory Changes Driving Digital Transformation in Clinical Trials: ICH M11 and CDISC DDF
Dr. Byungkwan Park, K3C Chair
10:20 - 10:50
Building the Digital Foundation for Clinical Research Innovation
Peter Van Reusel, CSO, CDISC
10:50 - 11:20
ICH M11 and CDISC Adoption by Global Regulatory Authorities
Dr. Ron Fitzmartin, CDISC
11:20 - 11:50
ICH M11 Implementation in Korea and Its Expected Benefits
Dr. Ki Young Huh, Seoul National University Hospital
11:50 - 13:00
Lunch & Networking
13:00 - 15:00
Session 2: The Future of CDISC: DDF, USDM, and Next-Generation Data Standards
Dr. Ki Young Huh, Seoul National University Hospital
13:00 - 13:30
CDISC Open Rules: Progress, Performance, and Foundations for the Future
Tomás Sabat Stöfsel, Co-Founder & CEO Verisian
13:30 - 14:00
Introduction to SDTMIG v4.0: Key Updates and What’s New
Hyunsoo Lee, JNPMEDI
14:00 - 14:30
From Protocol to Data: Clinical Trial Digitalization with CDISC USDM and AI
Dr. Eunhye Lee, C&R Research
14:30 - 15:00
AI-Assisted CDISC SDTM Generation
Gihwan Kim, Clupea
15:00 - 15:20
Coffee Break & Networking
15:20 - 17:30
Session 3: Practical Applications of CDISC and Innovation
Dr. Eunhye Lee, C&R Research
15:20 - 15:50
Case Study: CDISC Implementation - Lessons Learned & Best Practices
Sanggi Lee, C&R Research
15:50 - 16:20
Applying the Estimand Framework in ADaM: From Concepts to Implementation
Sujin Park, Naver
16:20 – 16:50
Define-XML Origin: Lessons Learned Before Automating CDISC
Miae Lee, JNPMEDI
16:50 – 17:20
From Standardized Clinical Data to Actionable Safety Review
Euiyeon Cho, P&D Solution; Noriki Naruse, Revvity Japan; and Daisuke Sakai, Revvity Japan
17:20 - 17:30
Closing Remarks
Gihwan Kim, K3C Vice Chair, Clupea