2022 China Interchange Program
Day 1 Recordings
All times in China Standard Time
Day 1 Recording Pt. 1
Due to a minor technical difficulty, we had to stop the recording and re-start it, which generated a second recording of the last ~30mins of Day 1.
8:30 - 10:15
Session 1: Opening Plenary & Keynote Presentation
Chair: Dr. Victor Wu, Beijing Data Science Express Consulting Co., Ltd., C3C Chair
8:30 - 8:35
Housekeeping
Bernard Klinke, Virtual Experience Mgr., CDISC
8:35 - 8:45
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
8:45 - 9:00
State of the CDISC Union
Rhonda Facile, Dr. Sam Hume, Sheila Leaman, Vice Presidents, CDISC
9:00 - 9:45
Keynote Presentation: Streamline Assessing Clinical Trial Data with Standards Using FDA NDAs and CRs as Examples
Dr. Wenjun Bao, JMP, CDISC Board of Directors
9:45 - 10:15
FDA-CDER Presentation
Helena Sviglin, FDA-CDER
10:15 - 10:45
Break
10:45 - 12:30
Session 2: CDISC Updates, Part I
Chair: John Wang, dMed Biopharmaceutical, C3C
10:45 - 11:15
CDISC Open Strategy
Charles Shadle, CDISC
11:15 - 11:45
CDISC Education Certification Program
John Ezzell, CDISC
11:45 - 12:10
Exploration of Data Management Automation 数据管理自动化探索
Lily Zhao, Innovent
12:10 - 12:30
Panel Discussion Meeting CDISC Authorized Instructors
CDISC Authorized Instructors
12:30 - 13:30
Lunch
13:30 - 15:00
Session 3: Regulatory Submission and Review
Chair: Shenglin Zhang, JIXING Bio.
13:30 - 14:00
Data Submission Package Translation and Validation
Xue Hu/Dr. Victor Wu, Data Science Express北京迪时咨询有限公司
14:00 - 14:30
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
14:30 - 15:00
Clinical Trial Data Visualization Application Based on CDISC Standards
Elma Hu, Tigermed
15:00 - 15:30
Break
15:30 - 17:30
Session 4: Artificial Intelligence & Real World Data/Evidence
Chair: Prof. Wen Zehuai, 广东省中医院Chinese Traditional Hospital of Guangdong Province
15:30 - 16:00
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
16:00 - 16:30
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.
16:30 - 17:00
Artificial Intelligence, Medical Device Registration Data Reporting Requirements
Mengya Li, National Center for Cardiovascular Disease
17:00 - 17:10
Day 1 Closing Remarks
10:30 - 11:00
Break
8:30 - 10:30
Session 5: CDISC Updates, Part II
Chair: Stanley Wei, Novartis
8:30 - 9:00
State of CDISC Standards
Amy Palmer, CDISC Head of Standards Development
9:00 - 9:30
CDISC SEND Presentation
Lou Ann Kramer, CDISC
9:30 - 10:00
Using LOINC in Regulatory Submissions
Dr. Jozef Aerts, XML4Pharma
10:00 - 10:30
CDISC CORE
Peter Van Reusel, CSO, CDISC
NOTE: Peter Van Reusel's presentation was presented as a recording with a powerpoint from a previous interchange
Day 2 Recording
Day 2
11:00 - 12:30
Session 6: Impact of CDISC Standards on Business Optimization
Chair: Ruiling Peng, Beijing Improve-Quality
11:00 - 11:30
A Simplified Low-Code Tool to Execute Logics Against Clinical Data
Haiping Yu, dMed
11:30 - 12:00
Application of CDISC Standard in developing Risk-Based Quality Management (RBQM) system
Yi Lu, Tigermed
12:00 - 12:30
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
12:30 - 13:30
Lunch
13:30 - 15:30
Session 7: Implementation Use Cases
Chair: Billy Xin, EUCURE BioPharma
13:30 - 14:00
CRF Question Text-Driven SDTM aCRF, Mapping Specification and Programs Automation
Haiqiang Luo, Kelun-Biotech科伦
14:00 - 14:30
Practice and Discussions on TAUGs implementations for oncology studies
Sen Fan, CSPC Pharmaceutical Group Ltd.
14:30 - 15:00
ADaM Implementation of irAE Analysis irAE分析的ADaM实施
Haiying Qiao, 康龙临床
15:00 - 15:30
RANO-BM Criteria and CDISC Application
Yawen Ouyang, Hongfang Zhou, Xuanzhu Biopharm 轩竹
15:30 - 16:00
Break
16:00 - 17:30
Session 8: Automation
Chair: Pamela Chen, Tigermed
16:00 - 16:30
Exploration of Open Source Technology in the Metadata Driven Clinical Trial Automation Process
Guoyan Zeng, Novartis
16:30 - 17:00
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
17:00 - 17:30
An Efficient Approach to Automatically Trace Back Clinical Data from Analysis to Source
Yudong Ren, Hengrui
17:30 - 17:40
Closing Remarks