2022 China Interchange Presentation Archive
Thanks to all who attended the 2022 China Virtual Interchange!
Day 1 Recordings
All times in China Standard Time
Day 1 Recording Pt. 1
Day 1 Recording Pt. 2
Session 1: Opening Plenary & Keynote Presentation
Chair: Dr. Victor Wu, Beijing Data Science Express Consulting Co., Ltd., C3C Chair
Housekeeping
Bernard Klinke, Virtual Experience Mgr., CDISC
Opening Remarks
Dr. Victor Wu / 吴崇胜, C3C, Data Science Express / CDISC中国协调委员会；北京迪时咨询有限公司
State of the CDISC Union
Rhonda Facile, Dr. Sam Hume, Sheila Leaman, Vice Presidents, CDISC
Presentation Files
Document
Keynote Presentation: Streamline Assessing Clinical Trial Data with Standards Using FDA NDAs and CRs as Examples
Dr. Wenjun Bao, JMP, CDISC Board of Directors
Presentation Files
Document
FDA-CDER Presentation
Helena Sviglin, FDA-CDER
Presentation Files
Session 2: CDISC Updates, Part I
Chair: John Wang, dMed Biopharmaceutical, C3C
CDISC Open Strategy
Charles Shadle, CDISC
Presentation Files
Document
CDISC Education Certification Program
John Ezzell, CDISC
Presentation Files
Document
Exploration of Data Management Automation 数据管理自动化探索
Lily Zhao, Innovent
Presentation Files
Panel Discussion Meeting CDISC Authorized Instructors
CDISC Authorized Instructors
Session 3: Regulatory Submission and Review
Chair: Shenglin Zhang, JIXING Bio.
Data Submission Package Translation and Validation
Xue Hu/Dr. Victor Wu, Data Science Express北京迪时咨询有限公司
Presentation Files
Document
Using Pinnacle 21 Enterprise™ for NMPA Data Submission 使用Pinnacle 21 企业版实施NMPA数据递交的案例分享
Haiquan Sun, Improve-Quality
Presentation Files
Document
Clinical Trial Data Visualization Application Based on CDISC Standards
Elma Hu, Tigermed
Presentation Files
Document
Session 4: Artificial Intelligence & Real World Data/Evidence
Chair: Prof. Wen Zehuai, 广东省中医院Chinese Traditional Hospital of Guangdong Province
Implementation of Real World Data for EMR EMR相关真实世界数据的运用
李庆娜 / Qingna Li 中国中医科学院西苑医院 / Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Presentation Files
Document
Implementation of AI for Data Collection of Clinical Trial 临床试验数据采集人工智能实践
周洪 / Hong Zhou 德派软件（北京）有限公司 / DAP Software (Beijing) Co., Ltd.
Presentation Files
Document
Artificial Intelligence, Medical Device Registration Data Reporting Requirements
Mengya Li, National Center for Cardiovascular Disease
Presentation Files
Document
Day 1 Closing Remarks
Session 5: CDISC Updates, Part II
Chair: Stanley Wei, Novartis
State of CDISC Standards
Amy Palmer, CDISC Head of Standards Development
Presentation Files
CDISC SEND Presentation
Lou Ann Kramer, CDISC
Presentation Files
Using LOINC in Regulatory Submissions
Dr. Jozef Aerts, XML4Pharma
Presentation Files
Document
CDISC CORE
Peter Van Reusel, CSO, CDISC
Presentation Files
Day 2 Recording
Day 2
Session 6: Impact of CDISC Standards on Business Optimization
Chair: Ruiling Peng, Beijing Improve-Quality
A Simplified Low-Code Tool to Execute Logics Against Clinical Data
Haiping Yu, dMed
Presentation Files
Application of CDISC Standard in developing Risk-Based Quality Management (RBQM) system
Yi Lu, Tigermed
Presentation Files
The Tool of Improving Clinical Data Quality Based on SDTM Datasets 基于SDTM数据集开发提高临床数据质量工具`
崔允辉, GCP Clinplus/普瑞盛医药
Presentation Files
Session 7: Implementation Use Cases
Chair: Billy Xin, EUCURE BioPharma
CRF Question Text-Driven SDTM aCRF, Mapping Specification and Programs Automation
Haiqiang Luo, Kelun-Biotech科伦
Presentation Files
Practice and Discussions on TAUGs implementations for oncology studies
Sen Fan, CSPC Pharmaceutical Group Ltd.
Presentation Files
ADaM Implementation of irAE Analysis irAE分析的ADaM实施
Haiying Qiao, 康龙临床
Presentation Files
RANO-BM Criteria and CDISC Application
Yawen Ouyang, Hongfang Zhou, Xuanzhu Biopharm 轩竹
Presentation Files
Session 8: Automation
Chair: Pamela Chen, Tigermed
Exploration of Open Source Technology in the Metadata Driven Clinical Trial Automation Process
Guoyan Zeng, Novartis
Presentation Files
Developing CDISC-CRF of special disease to promote the ecology construction of real-world data in China
Peng Xiaoxia, Center for Clinical Epidemiology, Beijing Children Hospital
Presentation Files
An Efficient Approach to Automatically Trace Back Clinical Data from Analysis to Source
Yudong Ren, Hengrui
Presentation Files
Closing Remarks