2024 Korea Interchange Presentation Archive
Session 1: Opening Ceremony & Welcome
Chair: Gihwan Kim, K3C Vice Chairman
Welcome Remarks from K3C
Dr. Byeongkwan Park, K3C Chairman
LSK Global PS Welcome Remarks
Dr. Young Jack Lee, LSK Global PS President
Welcome Remarks from KoNECT
Dr. In-Seok Park, KoNECT
Keynote Presentation: Digitalization and Data Standardization in Clinical Trials
Sanghee Kim, Korean Society for Clinical Development (KSCD)
Presentation Files
Session 2: Presentations by CDISC Leadership
Chair: Prof. Im Hee Shin, Past-Chair, K3C
CDISC Vision, Mission and Roadmap
Chris Decker, CDISC President & CEO
Presentation Files
CDISC Technical Landscape and Roadmap
Charles Shadle, CDISC
Presentation Files
Document
ICH M11, TransCelerate, CDISC & HL7: Driving the Adoption of Digital Protocol
Peter Van Reusel, CDISC Chief Standards Officer
Presentation Files
Session 3: Real World Data
Chair: Dr. Jisuk Jo, DreamCIS
A Multi-center Clinical Trial Monitoring System Based on CDISC Standards
Dr. Ki Young Huh, M.D.
Presentation Files
Utilizing Real-World Data for Sports Data Collection with CDISC Standards
Hyunmoon Kim, Ministry of Culture, Sports and Tourism
Presentation Files
Datafication of Disabilities: Innovative data-driven Approaches Using CDISC
Dr. Inpyo Jeon, Seoul Rehabilitation Hospital
Presentation Files
Document
Session 4: CDISC for Beginners
Chair: Gihwan Kim, Clupea, K3C Vice Chairman
ODM Presentation
Marcelina Hungria, DIcore Group
Presentation Files
Understanding Timing Variables: Basic and Applications in SDTM
Junseok Park, CMIC Korea
Presentation Files
How does SDTM programming work?
Hyunsoo Lee, JNPMEDI
Presentation Files
Session 5: Global Regulatory
Chair: Dr. Byeongkwan Park, K3C Chairman
BioInfra Welcome Remarks
Sangdeuk Lee, BIOINFRA CEO
KIT Welcome Remarks
Seonghoon Park, Vice President, KIT
FDA Study Data Policy Framework for Submitting Study Data to the U.S. Food and Drug Administration (FDA)
Helena Sviglin, FDA CDER
Presentation Files
PMDA Presentation
Hiromi Sugano, PMDA
Presentation Files
The Role of Standardized Study Data in Efficient and Effective Drug Application Reviews
Dr. Lilliam Rosario, FDA CDER
Presentation Files
ICH M11 Digital Clinical Protocol
Dr. Ron Fitzmartin, FDA CBER
Presentation Files
Status of CDISC in Korea
Woo-Sun Lee, MFDS
Presentation Files
Session 6: Non-Clinical
Chair: Dr. Cheolbeom Park, K3C
Shaping the Future of 'SEND' Together: The Importance and Impact of User Group Activities
Yoongi Kim, Korea Institute of Toxicology
Presentation Files
Key Challenges and Solutions in SEND Implementation
Minhaeng Lee, Corestemchemon
Presentation Files
Document
SEND Needs in the Industry (KOREA) and Expected Changes in the Future
Hyeyeong Lee, Biotoxtech
Presentation Files
Session 7: Clinical
Chair: Dr. Sookjung Jo, C&R Research
Implementing SDTM and ADAM in Oncology Trials
Dukhyun Kim, C&R Research
Presentation Files
Document
Overseas Regulatory Agency CDISC Submission Experience
Tina Pyo, Celltrion
Presentation Files
Document
Advanced SDTM/ADaM in Action: Case Studies and Practical Applications
Dr. Eunhye Lee, LSK Global PS
Presentation Files
Session 8: Digital Data Flow
Chair: Heeyoung Kim, Certara, K3C
USDM in action – from Protocol to SDTM
Dave Iberson-Hurst, data4knowledge ApS
Presentation Files
Document
Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations
Julie Ann Hood & Jennifer Manzi, Certara
Presentation Files
Navigating the Road to Submission: Unveiling the Impact of SDTM
Bremer Louw, Bioforum
Presentation Files