2024 Korea Interchange Program
10:00 - 11:00
Session 1: Opening Ceremony & Welcome
Chair: Gihwan Kim, K3C Vice Chairman
10:00 - 10:05
Welcome Remarks from K3C
Dr. Byeongkwan Park, K3C Chairman
10:05 - 10:15
LSK Global PS Welcome Remarks
Dr. Young Jack Lee, LSK Global PS President
10:15 - 10:25
Welcome Remarks from KoNECT
Dr. In-Seok Park, KoNECT
10:25 - 11:00
Keynote Presentation: Digitalization and Data Standardization in Clinical Trials
Sanghee Kim, Korean Society for Clinical Development (KSCD)
11:20 - 13:00
Session 2: Presentations by CDISC Leadership
Chair: Prof. Im Hee Shin, Past-Chair, K3C
11:20 - 11:50
CDISC Vision, Mission and Roadmap
Chris Decker, CDISC President & CEO
11:50 - 12:20
CDISC Technical Landscape and Roadmap
Charles Shadle, CDISC
12:20 - 13:00
ICH M11, TransCelerate, CDISC & HL7: Driving the Adoption of Digital Protocol
Peter Van Reusel, CDISC Chief Standards Officer
14:00 - 15:40
Session 3: Real World Data
Chair: Dr. Jisuk Jo, DreamCIS
14:00 - 14:30
A Multi-center Clinical Trial Monitoring System Based on CDISC Standards
Dr. Ki Young Huh, M.D.
14:30 - 15:00
Utilizing Real-World Data for Sports Data Collection with CDISC Standards
Hyunmoon Kim, Ministry of Culture, Sports and Tourism
15:00 - 15:30
Datafication of Disabilities: Innovative data-driven Approaches Using CDISC
Dr. Inpyo Jeon, Seoul Rehabilitation Hospital
16:00 - 17:30
Session 4: CDISC for Beginners
Chair: Gihwan Kim, Clupea, K3C Vice Chairman
16:00 - 16:30
ODM Presentation
Marcelina Hungria, DIcore Group
16:30 - 17:00
Understanding Timing Variables: Basic and Applications in SDTM
Junseok Park, CMIC Korea
17:00 - 17:30
How does SDTM programming work?
Hyunsoo Lee, JNPMEDI
9:05 - 11:15
Session 5: Global Regulatory
Chair: Dr. Byeongkwan Park, K3C Chairman
9:05 - 9:10
BioInfra Welcome Remarks
Sangdeuk Lee, BIOINFRA CEO
9:10 - 9:15
KIT Welcome Remarks
Seonghoon Park, Vice President, KIT
9:15 - 9:45
FDA Study Data Policy Framework for Submitting Study Data to the U.S. Food and Drug Administration (FDA)
Helena Sviglin, FDA CDER
9:45 - 10:15
PMDA Presentation
Hiromi Sugano, PMDA
10:15 - 10:30
The Role of Standardized Study Data in Efficient and Effective Drug Application Reviews
Dr. Lilliam Rosario, FDA CDER
10:30 - 10:45
ICH M11 Digital Clinical Protocol
Dr. Ron Fitzmartin, FDA CBER
10:45 - 11:15
Status of CDISC in Korea
Woo-Sun Lee, MFDS
11:30 - 13:00
Session 6: Non-Clinical
Chair: Dr. Cheolbeom Park, K3C
11:30 - 12:00
Shaping the Future of 'SEND' Together: The Importance and Impact of User Group Activities
Yoongi Kim, Korea Institute of Toxicology
12:00 - 12:30
Key Challenges and Solutions in SEND Implementation
Minhaeng Lee, Corestemchemon
12:30 - 13:00
SEND Needs in the Industry (KOREA) and Expected Changes in the Future
Hyeyeong Lee, Biotoxtech
14:00 - 15:30
Session 7: Clinical
Chair: Dr. Sookjung Jo, C&R Research
14:00 - 14:30
Implementing SDTM and ADAM in Oncology Trials
Dukhyun Kim, C&R Research
14:30 - 15:00
Overseas Regulatory Agency CDISC Submission Experience
Tina Pyo, Celltrion
15:00 - 15:30
Advanced SDTM/ADaM in Action: Case Studies and Practical Applications
Dr. Eunhye Lee, LSK Global PS
16:00 - 17:30
Session 8: Digital Data Flow
Chair: Heeyoung Kim, Certara, K3C
16:00 - 16:30
USDM in action – from Protocol to SDTM
Dave Iberson-Hurst, data4knowledge ApS
16:30 - 17:00
Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations
Julie Ann Hood & Jennifer Manzi, Certara
17:00 - 17:30
Navigating the Road to Submission: Unveiling the Impact of SDTM
Bremer Louw, Bioforum