Program of events is subject to change.
Virtual CDISC China Interchange - Day 1
8:30 - 17:00
All Times are in China Standard Time (GMT +8)
Session 1
Session Chair: Victor Wu, Data Science Express
8:30 - 9:00
Welcome Address & Opening Remarks
Dr. Jonathan Zung, Chair, CDISC Board of Directors; Victor Wu, China CDISC Coordinating Committee (C3C) Chair, Beijing Data Science Express
9:00 - 9:30
State of CDISC Standards and COVID-19 Interim User Guide
Bess LeRoy, CDISC Head of Standards Development
9:30 - 10:00
Study Data Standards and COVID-19
Helena Sviglin, U.S. FDA, Center for Drug Evaluation and Research (CDER)
Session 2
Session Chair: Shenglin Zhang, Taimei
10:30 - 11:00
Machine Learning FDA/CDISC Documents and Clinical Trial Data
Dr. Wenjun Bao, JMP Life Sciences and CDISC Board of Directors
11:00 - 11:30
CDISC Library API Update
Anthony Chow, CDISC Director of Data Science
11:30 - 12:00
Introduction of a New Concept: Analysis Results Data Model (ARDM)
Stanley Wei, C3C, Novartis
12:00 - 13:00
Lunch Break
Session 3
Session Chair: Lily Zhao, Innovent
13:00 - 13:30
How to Use WHODrug Global Chinese to Comply with CDISC SDTM and Regulatory Expectations
Damon Fahimi, Uppsala Monitoring Centre (UMC)
13:30 - 14:00
The Introduction of SDTM/ADaM Mapping Spec's Multifunctional Implementation Tool Developed with Excel-VBA
Minfang Cai, GCP ClinPlus
14:00 - 14:30
Good Data Quality
Chia Phei Kok, Visentic Solutions
Session 4
Session Chair: Yanhong Li, Merck
Coordinator: John Wang, dMed Biopharmaceutical Co., Ltd.
15:00 - 16:00
Panel Discussion
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Ruiling Peng, Improve Quality
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Liqin Jin, BeiGene
-
Victor Wu, Data Science Express
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Jiazhao Yuan, Sanofi
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Zibao Zhang, dMed Biopharmaceutical
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Yazhong Deng, Trust Medicine Consulting
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Stanley Wei, C3C, Novartis
Virtual CDISC China Interchange - Day 2
8:30 - 12:00
All Times are in China Standard Time (GMT +8)
Session 5
Session Chair: Ruiling Peng, Improve Quality
8:30 - 9:00
Keynote: CDE NMPA Presentation
Dr. Mingli Heng, Principal Reviewer, CDE NMPA
9:00 - 9:30
CDISC Conformance Validation Chinese Support
Xue Hu and Victor Wu, Beijing Data Science Express
9:30 - 10:00
Tools to Translate English Define Packages into Chinese for CDE Submission
王世家 (Shijia Wang), MacroStat
Session 6
Session Chair: John Wang, dMed Biopharmaceutical Co., Ltd.
10:30 - 11:00
Define-XML V2.0 Completion Guidelines – Analysis Result Metadata (Chinese support)
Xinyu Hua, dMed
11:00 - 11:30
Experience Sharing from CDASH Standards Translation Group
Max Chai, Yeedo MD and Lily Zhao, Innovent
11:30 - 12:00
Enhanced Pinnacle 21 Check for Chinese Study
Haiqiang Luo (罗海强), Hengrui
Virtual CDISC China Interchange - Day 3
8:30 - 12:00
All Times are in China Standard Time (GMT +8)
Session 7
Session Chair: Stanley Wei, C3C, Novartis
8:30 - 9:00
New Technology for CDISC (Graph Database, Python/R)
Vidya Muthukumar, IQVIA
9:00 - 9:30
All Roads Lead to Rome - Two ADaM Data Structures to Implement RECIST BOR with Confirmation
Siyou Li, Nanjing CR MedIcon Pharmaceutical Technology Co., Ltd.
9:30 - 10:00
ADaM IG 1.1 Compliant ADDATES and ADTTE development in a Oncology Study
Liang Guo, FMD K&L
Session 8
Session Chair: Pamela Chen, MacroStat (China) Clinical Research Co., Ltd.
10:30 - 11:00
How to generate SDTM LB dataset with a high quality mapping table？
Fengqing Li, Improve Quality
11:00 - 11:30
Data Collection Model - System Integration
Shenglin Zhang, Taimei
11:30 - 12:00
基于元数据的中英文CRF翻译实现思路 (CRF Translation Based on the Metadata from EDC)
George Xiang, TrustCRO