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 (Media)
Welcome Remarks from KoNect
Dr. In-Seok Park, Chairman of the Director, KoNect
Presentation Files (Media)
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 (Media)
Document
Welcome from the CDISC Board of Directors
Dr. Wenjun Bao, CDISC Board of Directors
Presentation Files (Media)
Keynote Presentation
Myeong-Hun Jeong, K-MEDI Hub
Presentation Files (Media)
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 (Media)
PMDA Presentation
Yuki Ando, PMDA
Presentation Files (Media)
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 (Media)
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 (Media)
Updates on CDISC Data Science Projects
Dr. Sam Hume, CDISC
Presentation Files (Media)
CDISC RWD Activities Update
Rhonda Facile, CDISC
Presentation Files (Media)
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 (Media)
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 (Media)
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
Presentation Files (Media)
Considerations in Converting Study Data
Mia Kim, DATA TEAMz Inc.
Presentation Files (Media)
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 (Media)
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 (Media)
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 (Media)
Document
Streamlining Academic Research Through Meta-Analysis Enhanced by CDISC Standards Integration
Yen Phan, University of Oxford
Presentation Files (Media)
SEND, The Need for the Implementation of the 3Rs Principles in Animal Tests
Ji-Won Kim, Korea Institute of Toxicology
Presentation Files (Media)
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 (Media)
Application of AI in Clinical Trials
Min-Seok Kim, JNPMEDI
Presentation Files (Media)
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
Presentation Files (Media)
CDISC Journey at Clinical Trial Center of Hospital in South Korea
Dr. Min-Gul Kim, Jeonbuk National University
Presentation Files (Media)
Closing Remarks