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