2023 Korea Interchange Program
8:30 - 10:00
Session 1: Opening Plenary
Chair: Dr. Im-Hee Shin, K3C Chair, Daegu Catholic University Medical Center
Crystal Ballroom B (3rd Floor)
8:30 - 8:40
Opening Ceremony and K3C Welcome
Dr. Im-Hee Shin, K3C Chair, Daegu Catholic University Medical Center
8:40 - 8:45
Welcome Remarks from KoNect
Dr. In-Seok Park, Chairman of the Director, KoNect
8:45 - 8:50
Welcome Remarks from K-MEDI Hub
Jin-Young Yang, Chairman and President, K-MEDI Hub
8:50 - 9:00
Distinguished Guest Welcome Remarks
9:00 - 9:15
Welcome Address & State of the CDISC Union
Dave Evans, CDISC President and CEO
9:15 - 9:30
Welcome from the CDISC Board of Directors
Dr. Wenjun Bao, CDISC Board of Directors
9:30 - 10:00
Keynote Presentation
Myeong-Hun Jeong, K-MEDI Hub
10:30 - 13:00
Session 2: Global Regulatory Presentations
Chair: Peter Van Reusel, CDISC
Crystal Ballroom B (3rd Floor)
10:30 - 11:00
FDA’s Study Data Policy Framework and Recent Activities
Helena Sviglin, FDA-CDER
11:00 - 11:30
PMDA Presentation
Yuki Ando, PMDA
11:30 - 12:00
Data Submission and Evidence Generation in Europe - an EMA Update
Eftychia-Eirini Psarelli, EMA
12:00 - 12:30
Status of CDISC in Korea
Woo-Sun Lee, MFDS
12:30 - 13:00
ICH M11 Clinical Electronic Structured Harmonized Protocol
Dr. Ron Fitzmartin, FDA-CBER
14:00 - 15:30
Session 3: Updates from CDISC Leadership
Chair: Sheila Leaman, CDISC
Crystal Ballroom B (3rd Floor)
14:00 - 14:30
State of CDISC Standards
Peter Van Reusel, CDISC
14:30 - 15:00
Updates on CDISC Data Science Projects
Dr. Sam Hume, CDISC
15:00 - 15:30
CDISC RWD Activities Update
Rhonda Facile, CDISC
16:00 - 17:30
Session 4: Real World Data + Implementation
Chair: Dr. Dong-Hoon Cho, Clupea
Crystal Ballroom B (3rd Floor)
16:00 - 16:30
Utilizing Real-World Data for Sports Data Collection with CDISC Standards
PD Hyeon-Moon Kim, Ministry of Culture, Sports and Tourism
16:30 - 17:00
Digital Healthcare and Medical Trends, and Future Outlook (RWD)
Dr. Dong-Cheol Cha, NAVER Medical Innovation Center
17:00 - 17:30
CDISC-Compliant Clinical Trial Imaging Management System: Focusing on Tumor Response Assessment Data in Clinical Trials
Dr. Kyung-Won Kim, Seoul Asan Medical Center
8:55 - 10:00
Session 5: CDISC Foundational, Part I
Chair: Gi-Hwan Kim, Clupea
Crystal Ballroom B (3rd Floor)
8:55 - 9:00
Welcome Remarks from Korea Institute of Toxicology
Dr. Seok-Joo Yoon, Korea Institute of Toxicology
9:00 - 9:30
How to use WHODrug for Compliance with CM Domain in the CDISC SDTM Standard
So-Hye Yoon, Uppsala Monitoring Centre
9:30 - 10:00
Considerations in Converting Study Data
Mia Kim, DATA TEAMz Inc.
10:30 - 12:00
Session 6: CDISC Foundational, Part II
Chair: Ji-Won Kim, Korea Institute of Toxicology
Crystal Ballroom B (3rd Floor)
10:30 - 11:00
Insights from Nonclinical Data Integration Analytics
Yoon-Gi Kim, Korea Institute of Toxicology
11:00 - 11:30
The SEND Vision: Updates from FDA-CDER
Jesse Anderson, FDA-CDER
11:30 - 12:00
Strategizing Successful Implementation of SDTM and ADaM
Seiko Yamazaki and Julie Ann Hood, Pinnacle 21 by Certara
13:00 - 14:30
Session 7: Regulatory & Academic Topics
Chair: Yoon-Gi Kim, Korea Institute of Toxicology
Crystal Ballroom B (3rd Floor)
13:00 - 13:30
Evaluating Safety, Quality and Traceability of Regulatory Submission Data
Dr. Wenjun Bao, JMP Statistical Discovery
13:30 - 14:00
Streamlining Academic Research Through Meta-Analysis Enhanced by CDISC Standards Integration
Yen Phan, University of Oxford
14:00 - 14:30
SEND, The Need for the Implementation of the 3Rs Principles in Animal Tests
Ji-Won Kim, Korea Institute of Toxicology
15:00 - 17:15
Session 8: Digital Data Flow
Chair: Dr. Byeong-Kwan PARK, LSK Global PS
Crystal Ballroom B (3rd Floor)
15:00 - 15:30
A Good Practice - Successful Implementation of CDISC Standards for Oncology Studies
Dr. Eun-Hye Lee, LSK Global PS
15:30 - 16:00
Application of AI in Clinical Trials
Min-Seok Kim, JNPMEDI
16:00 - 16:30
The Need for CDISC-Based Total Medical Data Platforms and the Current and Future of Drug Development Platforms
Dr. Dong-Hoon Cho and Gi-Hwan KIM, Clupea
16:30 - 17:00
CDISC Journey at Clinical Trial Center of Hospital in South Korea
Dr. Min-Gul Kim, Jeonbuk National University
17:00 - 17:15
Closing Remarks
Gi-Hwan Kim, K3C Co-Chair, Clupea