2026 Korea CDISC Day Presentation Archive
Thank you for attending the 2026 Korea CDISC Day!
Session 1: Global Regulatory Changes Driving Digital Transformation in Clinical Trials: ICH M11 and CDISC DDF
Dr. Byungkwan Park, K3C Chairman
Building the Digital Foundation for Clinical Research Innovation
Peter Van Reusel, CSO, CDISC
ICH M11 and CDISC Adoption by Global Regulatory Authorities
Dr. Ron Fitzmartin, CDISC Board of Directors
Implementation of ICH M11 in Korea and Expected Benefits
Dr. Ki Young Huh, Seoul National University Hospital
MFDS Presentation
Dr. Ju Sun Nam, Ministry of Food and Drug Safety (MFDS)
Session 2: The Future of CDISC: DDF, USDM, and Next-Generation Data Standards
Dr. Ki Young Huh, Seoul National University Hospital
CDISC Open Rules: Progress, Performance, and Foundations for the Future
Tomás Sabat Stöfsel, Co-Founder & CEO Verisian
Introduction to SDTMIG v4.0: Key Updates and What’s New
Hyunsoo Lee, JNPMEDI
From Protocol to Data: Clinical Trial Digitalization with CDISC USDM and AI
Dr. Eunhye Lee, C&R Research
AI-Assisted CDISC SDTM Generation
Gihwan Kim, Clupea
Session 3: Practical Applications of CDISC and Innovation
Dr. Eunhye Lee, C&R Research
CDISC Implementation - Turning CDISC Rules into Functions
Sanggi Lee, C&R Research
Applying the Estimand Framework in ADaM: From Concepts to Implementation
Sujin Park, Naver
Define-XML Origin: Lessons Learned Before Automating CDISC
Miae Lee, JNPMEDI
From Standardized Clinical Data to Actionable Safety Review