2026 Korea CDISC Day Program
10:00 - 10:20
Opening Remarks & Welcome Address
Dr. Byungkwan Park, K3C Chair, C&R Research; and Prof. Kyungsang Yu, Seoul National University College of Medicine and Hospital
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, C&R Research
10:20 - 10:50
Building the Foundation: Why Data Standards Matter for the Future of Clinical Trials
Chris Decker, President & CEO, 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
Prof. Ki-Young Huh, Seoul National University College of Medicine and Hospital
11:50 - 12:00
Q&A Session
All Session 1 Speakers
12:00 - 13:20
Lunch & Networking
13:20 - 15:00
Session 2: The Future of CDISC: DDF, USDM, and Next-Generation Data Standards
Prof. Ki-Young Huh, Seoul National University College of Medicine and Hospital
13:20 - 13:50
CDISC Open Rules: Progress, Performance, and Foundations for the Future
Dr. Peter Van Reusel, CTO, CDISC
13:50 - 14:20
Introduction to SDTMIG v4.0: Key Updates and What’s New
Hyunsoo Lee, J&P Medi
14:20 - 14:50
From Protocol to Data: Clinical Trial Digitalization with CDISC USDM and AI
Dr. Eun-Hye Lee, C&R Research
14:50 - 15:00
Q&A Session
All Session 2 Speakers
15:00 - 15:20
Coffee Break & Networking
15:20 - 17:30
Session 3: Practical Applications of CDISC and AI-Driven Innovation in Clinical Data
Dr.Eunhye Lee, C&R Research
15:20 - 15:50
Case Study : CDISC Implementation - Lessons Learned & Best Practices 1
Sanggi Lee, C&R Research
15:50 - 16:20
Case Study : CDISC Implementation - Lessons Learned & Best Practices 2
16:20 – 16:50
Case Study: AI-Assisted CDISC SDTM Generation
Kihwan Kim, Clupea
16:50 – 17:10
Enhancing Clinical Data Quality: CDISC Data Validation and Monitoring (TBD)
Noriki Naruse, Spotfire
17:10 - 17:20
Q&A Session
All Session 3 Speakers
17:20 - 17:30
Closing Remarks & Lucky Draw
Ki-Hwan Kim, K3C Vice Chair, Clupea