2026 CDISC China Interchange Program
Program is preliminary and subject to change.
9:00 - 10:40
Session 1: Opening Plenary and Keynote Presentations 开幕全体会议和主题演讲
John Wang, C3C Chair, Caidya 王军, C3C主席, 康缔亚
9:00 - 9:10
Opening
9:10 - 9:30
CDISC 360i Phase 2: Lessons Learned, Road Ahead, and a Future Digital Therapeutic Area User Guide
Chris Decker, CDISC President and CEO
9:30 - 9:50
CDISC 360i in Action: Demonstrating Value of End to End Connected Information
Julie Smiley, CDISC Chief Technical Officer
9:50 - 10:40
AI-Based Clinical Research Review: From an Institutional Perspective 基于AI的临床研究审查:从机构的角度
Yang Zhao, Professor, Nanjing Medical University 赵杨, 教授, 南京医科大学
10:40 - 11:00
Morning Break 上午茶歇
11:00 - 12:00
Session 2: Second Plenary
Ari Gao, C3C Vice Chair, MSD 高峰燕, C3C 副主席, 默沙东
11:00 - 11:20
Building Better Analysis Workflows - CDISC ARS Implementation 构建更优分析工作流程- CDISC ARS 实施
Carlos Pang, Associate Director Statistical Programmer, Novartis 庞超然，统计编程副总监，诺华
11:20 - 11:40
AI 赋能 CDISC SDTM aCRF 标准化注释：从效率提升到质量合规的实践探索
Dingping Li GCP Clinplus 李定平，AI DSBU负责人，普瑞盛医药
11:40 - 12:00
From the Findings of International Regulatory GCP Inspections: Focus on the Quality of Clinical Trial Data and Analysis 从国际监管GCP核查发现看临床试验数据与分析的质量关注
Carrie Zhang, VP, Head of Data Science Center, Global Product Development, Shanghai Henlius Biotech, Inc. 张玥, 产品开发部副总裁兼数据科学中心负责人,上海复宏汉霖生物技术股份有限公司全球
12:00 - 13:30
Lunch Break 午餐时间
13:30 - 14:30
Session 3: AI Application in CDISC Standards AI 在CDISC 标准中的应用
Qianqian Cheng, Principal Statistical Programming Lead, JNJ 成倩倩,首席统计编程, 强生
13:30 - 13:50
AI-Native SDTM Automation AI-Native SDTM 自动化
Hao Chen, Director, Data Intelligence. Scientific Programming Intelligent Solution, BeOne 陈浩，数据智能总监，科学编程智能解决方案，百济神州
13:50 - 14:10
AI‑Enabled Synthetic Data Generation for Clinial Trials 人工智能赋能的合成数据生成
Yuting Ji, Associate Director，MSD 冀宇婷，副总监，默沙东
14:10 - 14:30
From Project Compliance to Enterprise Consistency: AI-Driven CDISC Data Governance 从项目级合规到企业级一致：AI 驱动的 CDISC 数据治理体系
Jiayu Xu, Senior Statistical Programmer，Huadong Medicine 许嘉煜，高级统计编程师，华东医药
14:30 - 15:30
Session 4: Digital Design & Innovation in Clinical Trials
Joy Li, C3C Member, Xiyuan Hospital of China Academy of Chinese Medical Sciences 李庆娜, C3C成员，中国中医科学院西苑医院
14:30 - 14:50
Modernizing TMF Management: Applying AI to Drive Quality, Completeness, and Efficiency 智能化TMF管理: 以AI赋能质量、完整度与效率提升
Wei Du, Life Sciences Director, TransPerfect 杜玮，生命科学总监，创博
14:50 - 15:10
Updates about ICH M11, USDM and DDF ICH M11、CDISC USDM和 DDF的最新进展
Zibao Zhang, VP, Taimei 张子豹，副总裁，太美智研
15:10 - 15:30
SAS Viya AI-Native Hands-on: Bridging High-Performance Compute and Open-Source Ecosystems in CDISC pipelines SAS Viya AI 原生实操演练：CDISC 数据流中的高性能计算与开源生态融合
TianLun Gu， Director of Data Science Products SAS VSTECS 顾天伦 伟仕佳杰 SAS 客户部数据科学产品总监
15:30 - 16:00
Afternoon Break下午茶歇
16:00 - 16:50
Session 5: Regulatory
Jintao Shi, Expert Data Manager, BI 史金桃 数据专家，勃林格殷格翰
16:00 - 16:25
Shaping the Future of Regulatory Data in the AI Era – An EMA Perspective
Eftychia-Eirini Psarelli, European Medicines Agency
16:25 - 16:50
Multi-Regional Data Submission/AI Implementation 多地区数据递交/人工智能应用
Victor Wu, C3C Honored Chair, Data Science Express 吴崇胜, C3C荣誉主席, 迪时咨询
16:50 - 17:30
Session 6: CDISC Open Source Usage
Haibo Wang, C3C member，GCP Clinplus 王海波，C3C成员，普瑞盛数据科学事业部总经理
16:50 - 17:10
CDISC CORE
Zoe Cai , Sr. Statistical Programmer, Sanofi 蔡徐思乔, 高级统计程序员，赛诺菲
17:10 - 17:30
A Pioneer's Journey with Admiral: Implementing ADaM for a Prostate Cancer Study with PCWG-Modified RECIST
Ziwei Zhang, Senior Principal Statistical Programmer, Novartis 张紫微, 高级首席统计程序员, 诺华
17:30 - 18:00
Session 7: Panel Discussion
Shijia Wang，Associate Director，Tigermed 王世家，副总监，泰格医药
Panelists:
- Hao Chen，Director, Data Intelligence, Scientific Programming Intelligent Solution， BeOne
陈浩，数据智能总监，科学编程智能解决方案，百济神州 - John Wang, C3C Chair, Caidya
王军, C3C主席, 康缔亚 - Stanley Wei, C3C Vice Chair, Novartis
魏志军, C3C副主席, 诺华 - Victor Wu, C3C Honored Chair, Data Science Express
吴崇胜, C3C荣誉主席, 迪时咨询 - Zibao Zhang, General Manager, Union Laiya (Shanghai)
张子豹, 总经理, 有临来雅
18:00 - 18:15
Closing Remarks 闭幕
John Wang, C3C Chair, Caidya 王军，C3C主席，康缔亚
18:30 - 20:30
Evening Networking Event (Invited Speakers, Sponsors)
9:00 - 10:40
Session 1: Opening
Shijia Wang, Associate Director, Tigermed 王世家, 副总监, 泰格医药
9:00 - 9:10
Opening
9:10 - 9:30
Common Questions and Best Practice in QRS Data Handling QRS 数据处理中的常见问题与最佳实践
Jintao Shi, Expert Data Manager, BI 史金桃 数据专家，勃林格殷格翰
9:30 - 9:50
Let LLMs Do What They Do Best: Hybrid Pipeline and Guardrail Design for AI Medical Coding 让 LLM 只做它擅长的事：AI 医学编码的混合管道与护栏设计
Lee Wan, Senior Manager，Tigermed 万里行，高级经理, 泰格医药
9:50 - 10:10
Practical Application of CDISC-Based TDM 基于CDISC的精准用药辅助系统实战
Lang Chao, Director, Lianren Digital Health Technology Co., Ltd. 郎超, 产品总监，联仁健康医疗大数据科技股份有限公司
10:10 - 10:30
Q&A
10:30 - 11:00
Morning Break 上午茶歇
11:00 - 12:30
Session 2: CDISC Frontier
Chunpeng Zhao, Associate Director, Statistical Programming, BeOne; 赵春鹏, 统计编程副总监, 百济神州
11:00 - 11:20
Benefit Risk Assessment in Clinical Data Analysis 获益-风险评估中的临床数据分析
Qianqian Cheng, Principal Statistical Programming Lead, JNJ 成倩倩,首席统计编程, 强生
11:20 - 11:40
SDTMIG V4 Highlights SDTMIG V4 更新分享
Joy Li, C3C Member, Xiyuan Hospital of China Academy of Chinese Medical Sciences 李庆娜, C3C成员, 中国中医科学院西苑医院
11:40 - 12:00
AI Native CRF SDTM Annotation
Wei Wang, Senior Statistical Programmer, BeOne 王伟，高级统计程序员，百济神州
12:00 - 12:20
Q&A
12:20 - 12:30
Closing