Program of events is subject to change.
Session 1: Opening Plenary & Regulatory Update, Part I
8:30 - 10:10
Chair: 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
Grand Ballroom II - III
8:30 - 8:40
Opening Remarks
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
8:40 - 9:00
State of the CDISC Union
Dave Evans, CDISC President and CEO
9:00 - 9:10
Opening Welcome from the CDISC Board
Dr. Wenjun Bao, JMP Life Sciences, SAS Institute Inc., CDISC Board of Directors
9:10 - 9:40
SEND for CBER
Dr. Lisa Lin, FDA CBER
9:40 - 10:10
US FDA CDER Presentation
Helena Sviglin, FDA CDER
Break
10:10 - 10:40
Session 2: Second Opening Plenary and Regulatory Update, Part II
10:40 - 12:20
Chair: John Wang, dMed Biopharmaceutical, C3C
Grand Ballroom II - III
11:20 - 11:50
Keynote Presentation: CDE Representative
CDE Representative Invited
10:40 - 11:20
主旨演讲：医院系统真实世界数据CDISC模型应用 Keynote Presentation: Applications of Real World Data in Hospital Systems to the CDISC Model
Prof. Yao Chen, Peking University 姚晨 教授, 北京大学第一医院医学统计室主任、北京大学临床研究所副所长、海南真实世界研究院副院长
11:50 - 12:20
Panel Discussion
Lunch
12:20 - 13:30
Session 3, Track A: Implementation Use Cases
13:30 - 15:00
Chair: Ruiling Peng, Beijing Improve-Quality Technology Co., Ltd., C3C
Grand Ballroom III
13:30 - 14:00
如何应用CDISC标准化外部数据 How to standardize the external data with CDISC?
Ruirui Ni, Ting Li / 倪瑞瑞, 李婷, 上海杉互健康科技有限公司
14:00 - 14:30
中国数据递交之aCRF自动化 Automation of aCRF for CDE Submission
Mengsheng Xie / 谢蒙生, 圣方
14:30 - 15:00
中国数据递交之符合性检验工具 CCSCC: A Conformance Check Tool of Study Data for Submission to NMPA
Ming Li, Liang Guo / 李鸣, 郭亮, 昆翎
Session 3, Track B: Experience with Therapeutic Area User Guides & COVID-19 Impact
13:30 - 15:00
Chair: Billy Xin, Shanghai Benemae Pharmaceutical Corp, C3C
Grand Ballroom II
13:30 - 14:00
COVID-19影响 Assessment of COVID-19
Ari Gao / 高峰燕, MSD
14:00 - 14:30
CDISC标准在CAR-T试验中的应用 CDISC Standards Application in CAR-T Trial
Yan Fang, 科济生物
14:30 - 15:00
CDISC认证讲师面对面(问答)：CDISC实施问题 Meeting with CDISC Authorized Instructors (Q & A): Questions on CDISC Implementation
CDISC Authorized Instructors
Break
15:00 - 15:30
Session 4: CDISC Standards and Drug Development
15:30 - 17:30
Chair: Shenglin Zhang, Jiaxing Taimei Medical Technology Co., Ltd, C3C
Grand Ballroom II - III
15:30 - 16:00
CDISC中国更新及超越CDISC之实施 CDISC China Update and Beyond CDISC in Data Standards Implementation
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
16:00 - 16:30
应用CDISC整合不同研究的数据支持安全性综合总结 CDISC Standards Application in Integrated Summary of Safety (ISS)
Yisong Liu / 刘一松, 医普科诺Improve-Quality
16:30 - 17:00
图数据库技术在临床元数据库的应用 Application of Graph Database Technology in Clinical Metadata Repository
Haiping Yu / 虞海平 dMed Biopharmaceutical
17:00 - 17:30
BIMO的准备 – 案例分享 BIMO Preparation A Case Study
Chun Gong, Xuhua Deng, CR Medicon
Session 5: CDISC Updates
8:30 - 10:30
Chair: Yanhong Li, Merck, C3C
Grand Ballroom II - III
8:30 - 9:00
CDISC’s RWD Activities
Rhonda Facile, CDISC VP, Development Opportunities
9:00 - 9:30
State of CDISC Standards
Amy Palmer, CDISC Head of Standards Development
9:30 - 10:00
CDISC Library Update
Anthony Chow, CDISC Director of Data Science
10:00 - 10:30
CDISC Roundtable
Break
10:30 - 11:00
Session 6, Track A: Real World Data / Evidence and Artificial Intelligence
11:00 - 12:30
Chair: Fang Lu, Xiyuan Hospital, C3C
Grand Ballroom III
11:00 - 11:30
中国国家医保信息编码标准化概况及进展 General Situation and Progress of China's National Medical Insurance Information Coding Standardization
Hongwei Cai / 蔡宏伟, 西安交通大学第一附属医院 The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
11:30 - 12:00
数字化赋能临床研究全生命周期 Digitalization Empowerment to Full Cycle of Clinical Trials
Yonglong Zhuang / 庄永龙, 北京百奥知信息科技有限公司 BeiJing BioKnow
12:00 - 12:30
标准数据如何促进医药研发 How Data Standards Enhance the Pharmaceutical R&D
Chris X. Guo, Remegen 荣昌生物制药
Session 6, Track B: CDISC Core
11:00 - 12:30
Chair: Pamela Chen, MacroStat (China) Clinical Research Co., Ltd., C3C
Grand Ballroom II
11:00 - 11:30
动物试验概要(TS)域初窥 A Peep into the Trial Summary Domain for Non-clinical Studies
Tingting Wu, Ying Zhang, Nanjing CR Medicon
11:30 - 12:00
实验室检查分析数据集CTCAE实现可溯源性的好方法 A Better Traceability Approach for LAB CTCAE Analysis Dataset
Junyang Liu / 刘俊阳, dMed Biopharmaceutical
12:00 - 12:30
相对时间变量的区分使用 Differentiate the Relative Timing Variables
Qingmin Meng , Shiyuan Dong / 董施源
Lunch
12:30 - 13:30
Session 7, Track A: Tools and Automation
13:30 - 15:00
Chair: Stanley Wei, Novartis, C3C
Grand Ballroom III
13:30 - 14:00
一键生成NMPA数据递交包 Click Button to Prepare the NMPA eData Submission Package
Min Li, Xinyu Li /李敏, 李欣宇, Bayer HealthCare
14:00 - 14:30
高效生成精准SDTM的新自动化工具 New Automation Ways to Efficiently Create Accurate SDTM
Shijia Wang / 王世家 Tigermed-Macrostat
14:30 - 15:00
SDTM符合性规则翻译及Openchecks工具包 SDTM Conformance Rules Chinese Translation and Openchecks Toolkit
Huan Li / 李欢, Eli Lilly
Session 7, Track B: CDISC Basics
13:30 - 15:00
Hongwei Cai / 蔡宏伟, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, C3C
Grand Ballroom II
13:30 - 14:00
数据管理员SDTM入门 Don’t Panic: A Data Manager’s Guide to SDTM
Lanjin Jin, Boehringer-Ingelheim
14:00 - 14:30
多次入选与筛选在SDTM及分析中的考量 Consideration of Re-Enroll and Re-Screen in SDTM and Analysis
Chen Chen / 陈晨, Hengrui
14:30 - 15:00
基于CDASH创建CRF模板库 Creating CRF Library Based on CDASH
Jingfang Wu / 武敬芳, 普瑞盛
Break
15:00 - 15:30
Session 8: Closing Plenary - Regulatory Submissions
15:30 - 16:40
Chair: Yazhong Deng, Beijing Trust Medical Consulting Co. Ltd, C3C
Grand Ballroom II - III
15:30 - 16:30
数据递交专题讨论 Data Submission Panel Discussion
Panelists:
-
Victor Wu (迪时, C3C)
-
Jintao Shi (BI)
-
Yuanyuan Chen / 陈媛媛 (Wuxi Clinical)
-
Liqing Zhang / 张立强 (韧致)
-
Jianfeng Ye (Sanofi)
-
Shan Wan (Sanofi)
-
Zhuoyun Li /李卓昀 (Novartis)
16:30 - 16:40
Closing Remarks
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