2023 China Interchange Presentation Archive
Session 1: Opening Plenary
Ballrooms I + II
Opening Welcome
Victor Wu, Beijing Data Science Express Consulting Co., Ltd
Welcome Address: CDISC Strategy and the Future
Dave Evans, CDISC President and CEO
Presentation Files
Keynote Presentation: R for Submission and CDISC Open-Source Alliance
Michael Stackhouse, Atorus Research
Presentation Files
Document
CDISC RWD Activities Update
Rhonda Facile, CDISC
Presentation Files
Session 2: Second Plenary
John Wang, Caidya
Ballrooms I + II
State of the CDISC Standards
Christine Connolly, CDISC
Presentation Files
Keynote Presentation: New CDISC Data Submission Standards Implementation with Intelligent Assistance
Jianfeng Ye, Sanofi
Presentation Files
CDISC China Update and Metadata-Driven Automation in CDISC Implementation
Victor Wu, Beijing Data Science Express Consulting Co., Ltd.
Presentation Files
Panel Discussion: Standardization and Automation/AI Assistant
Session 3A: Efficient Start
Lily Zhao, Innovent
Ballroom I
Efficient Data Standardization Through AI 通过AI更方便地进行数据的标准化
Bogong Zhu 朱博贡, 上海耀乘健康科技有限公司
Presentation Files
CDASH Library Implementation in EDC Setup - to Improve the Efficiency 构建标准库在EDC构建应用中分享--提升建库效率
Shouzhu Zhao 赵守柱, 北京百奥知信息科技有限公司
Presentation Files
Document
Application of Standard Library According to CDISC in Outsourcing Projects 标准库在外包项目中的应用
Chaoyi Xie 谢超轶, Luye Pharmaceutical Group Co., Ltd 绿叶制药集团有限公司
Presentation Files
Document
Session 3B: Automation
Yazhong Deng, TrustCRO
Ballroom II
Automating aCRF-SDTM Mapping: NLP and Machine Learning Approach for Efficient Data Annotation 利用NLP和机器学习自动化aCRF-SDTM映射
Lee Wan, Tigermed-MacroStat
Presentation Files
Document
The Big Changes for Annotated CRF Submission to Health Authorities
Lanlan Peng 彭兰岚, Sanofi
Presentation Files
Metadata Repository (MDR)：E2E Data Transparency and Traceability
Kai Zhao, Tian Shen Cong; MSD
Presentation Files
Document
Session 4A: Preparation for Data Submission 1
Pamela Chen, Tigermed-MacroStat
Ballroom I
Build SDTM Automation Platform 构建SDTM自动化平台
Chong Liu 刘冲; 普瑞盛（北京）医药科技开发股份有限公司
Presentation Files
Document
SAS Cloud-Native Technology Accelerates Clinical Research Intelligence 云原生技术加速临床研究智能化进程
Tianlun Gu 顾天伦，赛仕软件（北京）有限公司
Presentation Files
Document
Preparing for Data Driven Submissions
Peng Li 李鹏, Sanofi
Presentation Files
Practices Sharing of Submitting NDA to NMPA for Vaccine MRCT Project 疫苗MRCT项目向NMPA递交NDA的实践分享 苏冠语 郭亮
昆翎 ClinChoice
Presentation Files
Session 4B: Therapeutics Area
Billy Xin, BIOCYTOGEN
Ballroom II
CDISC 针灸治疗领域标准介绍
李庚，温泽淮, 广东省中医院，Jordan Li, National Institute of Health, National Cancer Institute, EVS
Presentation Files
Considerations for Standard Library Development of Data Collection in Vaccine Trial
Yazhi Wang, SDM Bio Service Inc.
Presentation Files
FDA Pilot Standard Safety Data Request
Qianqian Cheng, Janssen China R&D, Johnson & Johnson
Presentation Files
Insights on Associated Persons Domains 对相关人（AP）域的认识
Xiaofang Zhang 张晓芳, 默沙东研发（中国）有限公司
Presentation Files
Session 5: Global Regulatory Update
Zibao Zhang, LC Ventures
Ballrooms I + II
FDA-CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chrissie Cai, FDA-CTP; and Christine Connolly, CDISC
PMDA Presentation
Yuki Ando, PMDA
Presentation Files
Data Submission and Evidence Generation in Europe - an EMA Update
Marcia Rueckbeil, EMA
Session 6A: Preparation for Data Submission 2
Ruiling Peng, 天津凯诺
Ballroom I
Experience and Problems Encountered During the Whole FDA BLA Submission and Review Cycle of an Oncology Drug
Lihong Wen 温利红, 天津凯诺医药有限公司
Presentation Files
It's Easy Peasy Submitting Data to the China NMPA, Really ??
Chenkai Lv, Roche
Presentation Files
Best Practice of Define-XML v2.1/Define-XML v2.1最佳实践
Alice Liu 刘慧, Jiangsu Hengrui Pharmaceutical Co., Ltd. 江苏恒瑞医药股份有限公司
Presentation Files
Session 6B: Academic and Information Technology
Fang Lu, 西苑医院
Ballroom II
DRG Grouping Supported by Standard Data Derived from Hospital Information System 医院信息系统标准数据支持下的DRG分组
Hongwei Cai 蔡宏伟, First Affiliated Hospital of Xi'an Jiaotong University
Presentation Files
Current Status, Limitations and Trends of CDISC Academic Research CDISC学术研究现况、局限性及趋势
Li Mengya 李梦雅, 国家心血管病中心 医学统计部
Presentation Files
Document
How Invisible Encoding put Impact on Data Storage and Display 看不见的编码是如何影响数据的储存以及显示
罗斯元 圣方医药研发有限公司
Presentation Files
Document
Session 7A: Conformance
Haibo Wang, GCP ClinPlus
Ballroom I
How to Draft Study Data Standardization Plan
Xin Wang 王昕, 昆翎 ClinChoice
Conformance Rules and Validation About Trial Design 试验设计域的符合性验证规则
Chaojun Wu 吴超珺, 天津凯诺医药有限公司
Presentation Files
Document
Issue Management in P21E
Jane Wang, Haili Yang; Parexel
Presentation Files
Document
Session 7B: Data Sharing
Hongwei Cai, First Affiliated Hospital of Xi’an Jiaotong University
Ballroom II
An Introduction to Privacy Methodology
Huan Lu 陆欢, Sanofi
Presentation Files
F2: FAIR and Filing - Assessing Data Fitness for FAIR and Filing
Siye Liu, Roche
Presentation Files
Difference of Clinical Trial Result Disclosure Between Clinicaltrial.gov and EudraCT
Yuanlin Ma 马原林, Sanofi
Presentation Files
Session 8: Discussion on CDISC Implementation
Victor Wu, 迪时咨询
Ballrooms I + II
ADaM Datasets: Balancing Automated and Manual Conformance Check
Seiko Yamazaki, Certara
Presentation Files
Draft Consensus on CDISC Implementation in China
Haibo Wang, GCP ClinPlus
Presentation Files
Document
Panel Discussion
Closing Remarks