Archives: Agenda
TECHNOLOGY SPOTLIGHT 技术聚焦 – A Demonstration of Digital Display Labels in Clinical Trials Operations & Supply Chain 数字显示标签(DDL)在临床试验运营与供应链中的应用演示
- Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
- A demonstration of the functionality of DDLs; just in time labelling, lot & expiry update, multiple page count.
- Understanding the operational ability to securely & remotely update content & language.
- Integrating across IMP profiles, vials, bottles, blisters
- 探究数字显示标签(DDLs)的技术能力及其对临床试验供应带来的效益
- 现场演示数字显示标签(DDLs)的功能:实时/即时标签贴签、批号与有效期更新、多页面内容切换
- 深入了解其运营能力:如何安全地进行远程内容及语言更新
- 实现全方位集成整合:涵盖试验用药品(IMP)构型、西林瓶、药瓶及铝箔水泡眼包装(泡罩包装)
Technology Spotlight技术聚焦 Interplay between Privacy laws and GCP Guidelines数据隐私法与 GCP 指导原则的相互作用
Many countries across the globe have enacted privacy laws and now Healthcare Authorities and Ethics Committees mandate that Clinical Trial Applications contain appropriate data privacy language. The good news is that it is simple in the Life Science industry because Good Clinical Practices have always protected the Rights of the Patients since the Code of Nuremberg in 1949. Participants will understand how to do it right the first time, they will learn the key points of attention, so the clinical trial is not delayed.
全球许多国家已颁布隐私法。目前,各国医疗卫生当局和伦理委员会均强制要求临床试验申请(CTA)中包含适当的数据隐私表述。值得庆幸的是,生命科学行业在此方面有深厚积累——自1949年《纽伦堡法典》问世以来,”临床试验规范“(GCP)就一直致力于保护患者权益。本演讲/课程将帮助参会者了解如何从源头实现合规的正确路径,并深度剖析关键风控点,以避免临床试验的延误。
Morning refreshments and networking 上午茶歇与交流
| (Visit 3 booth at least) |
(请至少参观3个展位)
PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论:保持领先:重塑临床试验的关键趋势
Clinical development is being reshaped by technology, new regulations, and a patient=centric focus. This panel will analyse key trends, from virtual trials to AI, separating hype from reality and providing a practical roadmap for leading the next generation of clinical research.
临床开发正在受到技术、新法规和以患者为中心理念的重塑。本圆桌将分析从虚拟试验到 AI 的关键趋势,区分炒作与现实,并为引领下一代临床研究提供实用路线图。
- Practical Implementation of DCTs & Hybrid Models
- Integrating RWE, AI, and Advanced Analytics
- Evolving from Recruitment to True Engagement
- Adapting SOPs, Vendor Partnerships, and Risk Management
- Regional Variations in Adopting Next-Generation Trials
- DCT 与混合模式的实践落地
- 整合 RWE、AI 与高级分析
- 从患者招募迈向真正的患者参与
- 调整 SOP、供应商伙伴关系与风险管理
- 下一代试验在不同区域的采用差异
Afternoon refreshments and networking 下午茶歇及交流
Managing Complex Logistics for ADC and Bi-Specific Antibody Clinical Trials ADC 与双特异性抗体临床试验的复杂物流管理
Antibody-Drug Conjugates (ADCs) and Bi-Specific Antibodies (BsAbs) represent the cutting edge of targeted oncology therapeutics. The delicate balance of the ADC structure (linker, antibody, payload) and the intricate assembly of the BsAb (two distinct binding domains) impose unprecedented demands for coordination and control across every logistical step, from manufacturing to the patient’s bedside.
抗体偶联药物(ADC)和双特异性抗体(BsAb)代表了靶向肿瘤治疗的前沿。ADC 结构(连接子、抗体、载荷)的精密平衡,以及 BsAb(两个不同结合结构域)的复杂组装,对从产线到病床的每一个物流环节都提出了前所未有的挑战。
- Identifying Critical Vulnerabilities in ADC & BsAb Supply Chains
- Strategies from Point-of-Manufacture to Global Distribution
- How to Leverage IoT and Blockchain for End-to-End Traceability from Factory to Bedside
- Dynamic Strategies for Dose Escalation & Biomarker-Driven Patient Stratification
- Leveraging China’s Mature Biologics Supply Chain Ecosystem
- 识别 ADC 与 BsAb 供应链中的关键节点
- 从生产端到全球配送的策略
- 如何利用 IoT 与区块链实现从产线到病床的端到端可追溯性
- 剂量递增与生物标志物驱动患者分层的动态策略
- 借力中国成熟的生物制品供应链生态