Korea CDISC Day Program Session Category All Categories Biomedical Concepts Day 1 Tuesday, 24 June 2025 10:00 - 11:10 Session 1: Opening Ceremony and CDISC Updates Chair: Dr. Byeongkwan Park, K3C Chairman 10:00 – 10:05 Opening Remarks and Welcome Dr. Byeongkwan Park, K3C Chairman 10:05 – 10:10 Welcome Remarks Dr. Kyungsang Yu, Director, Clinical Trials Center, Seoul National University Hospital 10:10 – 10:40 360i Update Chris Decker, CDISC President & CEO 10:40 – 11:10 Technology-Enabled Standards: Leveraging Technology, Open-Source Solutions, and AI for Standards Automation Julie Smiley, CDISC VP, Data Sciences 11:10 - 12:40 Session 2: Practical Application of CDISC Standards Chair: Prof. Im Hee Shin, K3C Past Chair 11:10 – 11:40 Latest Updates on CDASH and SDTM Hyoback Lee, Medidata 11:40 – 12:10 Practical Applications of ADaM and Analysis Data Standards Dukhyun Kim, C&R Research 12:10 – 12:40 Case Studies of CDISC Implementation: Lessons Learned and Best Practices Dr. Eunhye Lee, LSK Global PS 12:40 – 13:40 Lunch 13:40 - 15:10 Session 3: Data Submission and Regulatory Requirements Chair: Dr. Sookjung Jo, C&R Research 13:40 – 14:10 Making It Work: Real-World CDISC Implementation in a Unified DM & STAT Team Soohee Jang, Chong Kun Dang 14:10 - 14:40 Challenges in Legacy Data Conversion for Global Submission Mihee Park, Daewoong 14:40 - 15:10 CDISC Data Validation and Error Resolution Methods Heeyoung Kim, CERTARA 15:10 – 15:40 Break 15:40 - 17:00 Session 4: Industry Landscape and CDISC Adoption Chair: Hyunsoo Lee, JNPMEDI, K3C 15:40 – 16:10 CDISC Standards and Real-World Evidence (RWE) Dr. Jisuk Jo, Dream CIS 16:10 – 16:40 Integration of Electronic Data Capture (EDC) with CDISC Standards Gihwan Kim, Clupea 16:40 – 17:00 Closing Remarks & Q&A Gihwan Kim, Clupea