Archives: Agenda

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1

What key aspects of inspection readiness should be considered right now?

Hosted By Claire Qin, Chief Strategy Officer, Intelligen AI; BioPharma Investor

ROUNDTABLE 2

Getting the best out of your sponsor – CRO partnership

Hosted by Megan Qin, Head of Medical Device Clinical Excellence Working Group, CMAC

ROUNDTABLE 3

Ensuring clinical quality assurance in supply chain management

Hosted By Daniel Gao, President, ISPE Supply Chain Committee

互动式圆桌会议为您提供与同行深入交流的独特机会，共同探讨行业关键挑战的解决方案并分享最佳实践。每场讨论由行业专家主持，聚焦单一议题，通过高互动形式拓展人脉网络，汲取他人经验智慧。
（每场圆桌讨论时长30分钟，参会者可轮换参与）

圆桌议题1：中国药企出海的机遇与挑战
主持嘉宾：秦祯，首席战略官，Intelligen AI

圆桌议题2：如何构建最优申办方-CRO合作伙伴关系
主持嘉宾：秦飞，卓越临床联盟医疗器械工作组负责人，CMAC

圆桌议题3：临床试验供应链质量管理保障机制
主持嘉宾：高晓伟，主席，ISPE供应链分会

As China’s clinical trial ecosystem evolves, there is a growing emphasis on patient-centric approaches to improve recruitment, retention, and overall trial outcomes. This session will explore strategies to enhance patient engagement, leverage digital health solutions, and address cultural and regulatory considerations for patient-centric clinical trials in China.

• Understanding the Shift Toward Patient- Centric Trials in China.
• Enhancing Patient Recruitment and Retention
• Digital Health and Remote Monitoring in Patient- Centric Trials.
• Regulatory and Ethical

随着中国临床试验生态系统的演进，聚焦患者需求的 模式正显著提升受试者招募、留存及整体试验质量。 本环节将探讨如何通过数字化健康解决方案增强患者 参与度，并解析中国患者中心式试验中的文化适应性 与监管要求

• 去中心化临床试验 DCT 的发展历程
• 国内外相关法规对 DCT 的指导要求
• DCT 技术在临床研究中的具体应用和实践
• 关于 DCT 发展趋势的展望和应对。

• Government & Regulation: From “Approver” to “Ecosystem Cultivator and Rule-Maker”.
• Pharmaceutical Companies: From “Drug Suppliers” to “Key Ecosystem Builders and Enablers”.
• Medical Institutions: From “Service Endpoints” to “Data-Driven Innovation Hubs”.
• Patient Population: From “Passive Recipients” to “Empowered Active Health Partners”.

• 政府与监管：从“审批者”到“生态培育者与规则制定者
• 医药企业：从”药品供应商“到”生态系统的关键构建者与赋能者“
• 医疗机构：从“服务终端”到“数据驱动的创新协同中心”
• 患者群体：从”被动受众“到”自我赋能的主动健康伙 伴

• Clarifying the differences in using the terms RWE vs
• Proving examples of RWE sources available: commercial, society, private.
• Case study to explain a detailed implementation of RWE to support an expanded indication for a medical device

• RWE（真实世界证据）与 RWD（真实世界数据）术语使用的区别
• 现有 RWE 来源的实例：商业数据库、学会数据、私有数据源
• 如何运用真实世界证据支持医疗器械适应症扩展的案例介绍

• Understanding the current biotech landscape.
• Top considerations for future development.
• Engaging a global CRO.

• 了解当前生物技术领域的发展态势
• 未来发展的关键考量因素
• 如何与全球 CRO 建立合作

• Summary of market data and where Phase 1 studies are being performed.
• What are investors looking for from Phase 1 clinical trial datasets?
• What and where can Phase 1 studies be done to meet or exceed market demands?
• Review relevant case studies given recent China Biotechs market success.

• 市场数据总结及一期临床试验开展地区分析
• 投资者对一期临床试验数据的关键需求
• 满足或超越市场需求的一期临床试验方案及实施地点
• 结合中国生物科技公司近期市场成功的相关案例研究

• New regulations and guidance around clinical trials in China: how will this impact you?
• Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor
• An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

• 中国临床试验新规解读：对中小型企业的实际影响
• 动态变化的 CRO/供应商生态应对策略
• 临床试验技术创新应用评估：有效方案与现存瓶颈
• 海南封关对中国医药企业的影响与机遇