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