Program
大会语言以中文为主，会议内容将持续更新，会议日程将以大会公布为准
The conference language is Chinese. For the most updated conference agenda, please refer to the notice from the organizer.
会前培训和研讨专题介绍 | ABOUT PRE-CONFERENCE WORKSHOP SESSIONS
Track A: 加强国内制药企业数据管理部门建设，满足国内外监管要求
随着我国制药行业的快速发展，对医药企业的数据管理和质量控制提出了更高的要求。为了帮助国内制药企业更好地建立和完善数据管理部门，满足日益提高的国内外药监管理的要求，本届会前研讨会，主题为“加强国内制药企业数据管理部门建设，满足国内外监管要求”, 旨在促进国内制药企业在数据管理质量建设方面的互动交流，促进国内制药企业数据管理部门的发展。研讨会将分为以下两个部分：
- 临床试验的国内外监管要求与现场核查
- 国内制药企业数据管理部门质量建设
Track A: Focus on Quality in Clinical Data Management to Meet the Regulatory Requirements
With the rapid development of China’s pharmaceutical industry, higher requirements for data quality have been put forward for clinical data management. To help domestic pharmaceutical companies better establish and improve their data management quality to meet the increasingly stringent regulatory requirements, this pre-conference seminar will focus on the theme of ” Focus on Quality in Clinical Data Management to Meet the Regulatory Requirements”, aiming to promote interaction and communication among domestic pharmaceutical/biotechnology companies in the field of data management in China The seminar will be divided into the following two parts,.
- Regulatory requirements and on-site inspection in clinical trials
- Key factors of quality in clinical data management
Track B: 关于临床数据管理领域新技术的探讨
在当今数字化、智能化的时代，临床数据管理领域正迎来前所未有的变革。新技术的不断涌现，为临床数据的高效收集和应用提供了强大支持。本专题聚焦临床数据管理领域的最新技术进展，深入探讨AI编码与SMART查询、DCT技术引导梳理、自带设备应用及ePRO经验等前沿话题，通过分享实践经验和案例，旨在推动临床数据管理水平，为临床研究提供有力支持。
Track B: New Technologies in DM World
In today’s digital and intelligent era, the clinical data management is experiencing unprecedented changes. The continuous emergence of new technologies provides strong support for the efficient collection and application of clinical data. This workshop focuses on the latest technological progress in the field of clinical data management and will discuss cutting-edge topics such as AI coding and SMART query, DCT guidance combing, bring your own device (BYOD) application and ePRO experience. By sharing practical experience and cases, this workshop aims to promote the level of clinical data management and provide strong support for clinical research.
大会专题介绍 | CONFERENCE SESSION DESCRIPTION
主旨演讲环节聚焦临床数据科学–创新与发展
本环节包含主旨演讲和专家小组讨论
Keynote Session focuses on the Innovation and Evolution toward Clinical Data Science
This session includes keynote speech and panel discussion.
专题1：基于风险的临床数据管理：从事后回顾性管理到主动预测性分析
随着机器学习和生成式AI技术的广泛应用，临床数据管理领域正在经历革命性的变革。本专题将深入探讨临床试验数据管理的演化过程，从传统的事后回顾性分析向当下的主动预测性分析转变。我们将分享这一转变过程中所面临的挑战、蕴藏的机遇以及最佳实践经验，共同探索在新技术下，临床数据管理领域的未来发展方向。
Session 1: Risk-based Data Management: Transitioning from Retrospective to Proactive to Finally Prevent Risk in Advance
With the widespread application of machine learning and generative AI technologies, the field of clinical data management is undergoing revolutionary changes. This session will delve into the evolution of clinical trial data management, transitioning from traditional retrospective analysis to the current trend of proactive predictive analysis. We will share the challenges, opportunities, and best practices encountered during this transformation. Let’s explore together the future direction of clinical data management in the era of new technologies.
专题2：向临床数据科学迈进：探索变革期新的能力需求和工作模式
临床数据管理正向临床数据科学转型发展。本专题将探讨在转型期，变革对于从业人员能力和公司组织体系的要求和需求；以及临床试验过程中，从方案设计到项目运营，就QbD方法学在临床数据科学中的工作模式进行深入讨论。
Session 2： The Transformation to CDS – Explore New Professional Capabilities and Working Model Required
Clinical Data Management (CDM) is now transforming to Clinical Data Science (CDS). This session is to explore the requirements and needs of CDM professionals’ capabilities and companies’ organizational systems during the transition period. In the process of clinical trial, from protocol design to project operation, the working mode of QbD methodology in clinical data science will be also discussed.
专题3：临床试验法规与标准
助力新药出海，熟悉掌握全球最新的法规要求和数据标准是基础出发点。本专题讨论围绕风险预测与评估、盲态保持和数据标准的更新，分享讨论临床试验数据管理的最佳应对。
Session 3: Regulation and Data Standard for Clinical Trial
To support global submission, catching up with most recent regulations and data standard updates globally is essential. This session will focus on risk-based data forecasts, blinding, and standard related updates, share and discuss best practices accordingly.
大会专题介绍 | CONFERENCE SESSION DESCRIPTION
专题6：真实世界数据治理与专病库建设
数据管理在真实世界数据治理中具有关键性的作用，它不仅能够保证数据的质量、安全和合规性，还能够促进数据的标准化、整合和有效利用，从而最大限度地发挥数据在医疗健康领域中的作用和价值。本专题主要围绕真实数据质量保证，隐私和安全保护，数据标准化和整合方面展开，同时针对前瞻性专病库建设对于真实世界数据价值展开深入讨论。
Session 6: Real-world Data Curation and Construction of Special Diseases Database
Data management plays a key role in real-world data curation. It not only ensures data quality, security, and compliance, but also promotes standardization, integration, and effective utilization of data, thereby maximizing the role and value of data in healthcare industry. This session focuses on real-world data quality assurance, privacy and security protection, data standardization and integration, while also delving into the value of prospective special disease database construction for real-world data.
专题4：新技术在临床数据管理领域的应用与未来
新技术（包括自动化工具和人工智能）正在迅速发展，而我们迫切需要在资源有限的世界中继续寻找提高质量和工作效率的方法。新技术在塑造未来方面处于领先地位，本专题旨在了解它们的好处、局限性和风险;学习和探索其应用，以推动技术创新和推进数据管理实践！
Session 4: The Applications and Future of New Technologies in Clinical Data Management
New technologies (including Automation Tools and Artificial intelligence) are rapidly evolving while we experienced pressing needs to continue to look for ways to enhance quality and work efficiency in a world with limited resources. New technologies are leading the way in shaping the future, this session aims to understand their benefits, limitations, and risks; to learn and explore their applications to drive technological innovation and advance data management practices!
专题5：数字化技术在临床试验中的探索与应用
数字化技术的不断突破与发展，对药物临床试验起到了推动作用。我们需要“以患者为中心”，不断开拓视野、突破边界、以创新模式，降低临床试验风险，以改善数据质量，提高工作效率。本专题从临床机构信息化建设以确保临床试验结果可靠性；可移动技术在临床试验应用中的探索，及临床试验中数字化技术对远程监查的支持等方面进行探讨。
Session 5: Exploration and Application of Digital Technology in Clinical Trials
The continuous breakthrough and development of digital technology has played a role in promoting drug clinical trials. We need to be “patient-centered”, constantly expand our vision, break through boundaries, and reduce clinical trial risks with innovative models to improve data quality and improve productivity. This session focuses on the digital construction of clinical institutions to ensure the reliability of clinical trial results. The exploration of the application of mobile technology in clinical trials, and the support of digital technology for remote monitoring in clinical trials will be discussed.
组委会 | PROGRAM COMMITTEE
Introducing the leading minds behind the #SCDM24 programme
张薇 Wei Zhang
[SCDM中国指导委员会主席、葛兰素史克（上海）医药研发有限公司医学开发部数据管理部门负责人 SCDM China Steering Committee Chair; Head of Data Management, GSK China R&D]
颜崇超 Charles Yan
[SCDM中国指导委员会副主席、上海盛迪医药有限公司临床数据科学中心副总经理 SCDM China Steering Committee Vice Chair; Vice President, Clinical Data Science Center, Shanghai Shengdi Medicine Co., Ltd.]
张玥 Carrie Zhang
[SCDM中国指导委员会委员、上海复宏汉霖生物技术股份有限公司副总裁，全球产品开发部数据科学中心负责人 SCDM China Steering Committee Member; Vice President, Data Science Center, Global Product Development, Shanghai Henlius Biotech, Inc.]
邓亚中 Yazhong Deng
[SCDM中国指导委员会委员、北京信立达医药科技有限公司总经理 SCDM China Steering Committee Member; General Manager, Beijing Trust Medical Consulting Co., Ltd.]
田正隆 Zhenglong Tian
[SCDM中国指导委员会委员、高博医疗集团临床研究中心首席战略官兼首席数据官 SCDM China Steering Committee Member; Chief Strategy Officer and Chief Data Officer, Clinical Research Center, GoBroad Healthcare Group]
黎婉珊 Joyce Lai
[SCDM中国指导委员会委员、默沙东研发（中国）有限公司全球临床数据管理中心亚太区高级总监 SCDM China Steering Committee Member; Senior Regional Director, Clinical Data Management, Global Data Management & Standards, MSD R&D (China) Co., Ltd.]
孙华龙 Hualong Sun
[SCDM中国指导委员会委员、苏州科林利康医药科技有限公司首席战略官 SCDM China Steering Committee Member; Chief Strategy Officer, Clinical Service Center]
张蕴 Sally Zhang
[SCDM中国指导委员会委员、艾昆纬医药科技（上海）有限公司数据管理部门资深总监 SCDM China Steering Committee Member; Sr Director, Head of Great China GDM, IQVIA]
倪丽萍Annie Ni
[SCDM中国指导委员会委员、辉瑞（中国）研究开发有限公司中国临床数据科学部临床数据汇集与处理业务负责人，总监 SCDM China Steering Committee Member; Director, Program Lead, Clinical Data Acquisition, China Clinical Data Sciences, Pfizer (China) Research and Development Co., Ltd.]