2024 China Interchange Program
8:00 - 8:30
Interchange Registration
8:30 - 10:00
Session 1: Opening Plenary
Victor Wu C3C, 迪时咨询
8:30 - 8:40
Interchange Opening
Victor Wu (C3C, 迪时咨询)
8:40 - 8:50
Welcome Address
Chris Decker, CDISC President and CEO
8:50 - 9:20
CDISC Vision: Rebuilding our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President and CEO
9:20 - 10:00
Speaker Invited
Speaker Invited
10:00 - 10:30
Morning Break
10:30 - 12:00
Session 2: Second Plenary
John Wang C3C, Caidya
10:30 - 11:00
New CDISC Analysis Results Standard
Bess LeRoy, CDISC
11:00 - 11:30
The TransCelerate / CDISC Digital Data Flow; M11
Chris Decker, CDISC President and CEO
11:30 - 12:00
Using Artificial Intelligence to Assist MedDRA to Improve the Accuracy and Consistency of AE Records in Clinical Trials人工智能辅助MedDRA提高药品临床试验中不良反应记录的精准性及一致性
Freddy Fei费嘉杰 , SAS
12:00 - 13:30
Lunch
13:30 - 15:00
Session 3A: Efficient Start & SDTM
Qianqian Cheng, JNJ
13:30 - 14:00
Implementation of Propensity Score Analysis in Real World Evidence Studies Based on CDISC Standards 基于CDISC标准的真实世界证据研究中倾向性评分分析的实施
Sisi Zhou 周思思, Parexel International
14:00 - 14:30
SDTM Datasets Review Report的实现思路与系统 Ideas and Systems for Implementing SDTM Datasets Review Report
许雪佳 Xuejia.Xu, GCP ClinPlus
14:30 - 15:00
SDTM 3.3 CHALLENGES
杨帆 Fan Yang, Novartis
13:30 - 15:00
Session 3B: End to End Implementation
Yazhong Deng C3C, TrustCRO
13:30 - 14:00
The Value and Practice Sharing of Data Science in Digital and Intelligent Clinical Trials 数字化时代临床试验数据科学价值与应用
Raymone Xu徐海涛, Tigermed泰格医药
14:00 - 14:30
Facilitating Rapid and Accurate Meta-Analysis in Public Health Emergencies: The Role of CDISC Standards in Academic Research
Yen Phan, University of Oxford
14:30 - 15:00
CDISC 360项目解读
Qingna LI 李庆娜, 北京西苑医院
15:00 - 15:30
Afternoon Break
15:30 - 17:00
Session 4A: Global Regulatory Update & AI
Pamela Chen C3C, Tigermed-MacroStat
15:30 - 16:00
Speaker Invited
Speaker Invited
16:00 - 16:30
AI Agent and its Applications in Clinical Trial Data Operations
Stanley Wei, Novartis
16:30 - 17:00
aCRF and SDTM integrated automation Tool based on NLP + ML
Shijia Wang, TigerMed
15:30 - 17:00
Session 4B: Safety Implementation
Billy Xin C3C
15:30 - 16:00
Comprehensive Adoption Strategy for the FDA Standard Safety Tables and Figures
Guowei Wu, Merck
16:00 - 16:30
A Novel Approach for the Algorithmic FMQ Analysis Dataset (ADALGFMQ)
Yuanyuan Dong, MSD
16:30 - 17:00
Enhancing Safety Signal Detection: Strategies for Creating FDA Medical Query Analysis Datasets
Huiru Chang, Siru Tang, Danfeng Fu, & Guowei Wu; MSD
8:30 -10:00
Session 5: CDISC Standards Updates & Submission Preparation
Zibao Zhang C3C, Uionlab
8:30 - 9:00
Digital Health Technologies (DHTs): A Path to Data Standardization
Christine Connolly, CDISC
9:00 - 9:30
TMF Update
Karen Roy, CDISC
9:30 - 10:00
Submission Success: Navigating the Maze of Documentation and Checks for Seamless Regulatory Submissions
Seiko Yamazaki & Julie Ann Hood, Certara
10:00 - 10:30
Morning Break
10:30 - 12:00
Session 6A: Preparation for Data Submission 2
Haiquan Sun 凯莱英临床(凯诺)
10:30 - 11:00
End-to-End R Submission from Roche Oncology Study
Chenkai Lv, Roche
11:00 - 11:30
基于R等多语言开发构建Pinnacle 21报告个性化管理平台：提升数据合规性与效率 Development and Construction of a Personalized Pinnacle 21 Report Management Platform Using R and Other Languages: Enhancing Data Compliance and Efficiency
Mengji Lin 林孟记, 北京方胜远临医药科技有限公司
11:30 - 12:00
Implementation and Harmonization End to End CDISC Standard CDASH-SDTM-ADaM in a Platform Trial Framework
Lei Zhang, Boehringer Ingelheim
10:30 - 12:00
Session 6B: Cross Function
Shenglin Zhang 箕星
10:30 - 11:00
Best Practices of Programmers on Master Protocols
Fu Wang & Mona Mo, Parexel
11:00 - 11:30
Designing an ADaM Dataset for Streamlined Drug-Induced Liver Injury Screening Analyses
Ben Gao, Danfeng Fu & Guowei Wu, MSD
11:30 - 12:00
ADaM popPK Dataset for NONMEM?? - A Programmer Point of View
Lin Liu, BeiGene
12:00 - 13:30
Lunch
13:30 - 15:00
Session 7A: ADaM Implementation
Haibo Wang 北京方胜远临医药科技有限公司
13:30 - 14:00
Current & Forthcoming CDISC ADaM Publications: An Overview
Guowei Wu & Cindy Stroupe, Merck
14:00 - 14:30
ADRECIST: a fully derived disease evaluation dataset （ADRECIST：一个完全衍生的疾病评估数据集）
Ping Zhang 张萍, Johnson & Johnson
14:30 - 15:00
创建LB/ADLB过程中遇到的问题和经验总结-案例分享 Summary of Problems and Experiences Encountered in the Process of Creating LB/ADLB - Case Sharing
Shuxin LI 李舒新, 凯莱英临床 凯诺
13:30 - 15:00
Session 7B: SDTM Implementation
Ari Gao, MSD
13:30 - 14:00
Do's and Don'ts for CRF Mapping
Alice Liu, Hengrui Pharmaceutical Company
14:00 - 14:30
Tips About Data Not Collected in cSDRG for Define.xml v2.0/v2.1 关于未采集数据在cSDRG中的呈现
Sophia Ye 叶谦颖, Parexel
14:30 - 15:00
Application Experiences in SEND Data Submission-Analysis of Similarities and Differences Between SEND and SDTM Generation
Chaojun Wu, 凯莱英临床 凯诺
15:00 - 15:30
Afternoon Break
15:30 - 17:05
Session 8: CDISC, AI & Future
John Wang C3C, Caidya
15:30 - 16:00
CDISC China update and Knowledge Frame of Clinical Data Science
Victor Wu, C3C 迪时咨询
16:00 - 17:00
Panel Discussion: CDISC, AI & Future
- Victor Wu C3C, 迪时咨询
- Zhijun (Stanley) Wei, Novartis
- Shijia Wang, Tigermed-MacroStat
- Michael Lai, Innovent
- Geng Li, 广东省中医院
17:00 - 17:05
Interchange Closing
Victor Wu, C3C 迪时咨询