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)

10:00 - 10:30

Tea Break

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

14:30 - 15:00

Tea Break

Session 4

Session Chair: Yanhong Li, Merck
Coordinator: John Wang, dMed Biopharmaceutical Co., Ltd.

15:00 - 16:00

Panel Discussion

  • Ruiling Peng, Improve Quality

  • Liqin Jin, BeiGene

  • Victor Wu, Data Science Express

  • Jiazhao Yuan, Sanofi

  • Zibao Zhang, dMed Biopharmaceutical

  • Yazhong Deng, Trust Medicine Consulting

  • 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

10:00 - 10:30

Tea Break

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

10:00 - 10:30

Tea Break

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