Archives: Agenda

• 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）

• Globalizing Early-Phase Development: Explores expanding opportunities for biopharmaceutical innovators to run Phase 1 trials internationally.
• Strategic Regional Advantages: Showcases destinations like Australia that offer rapid regulatory pathways, cost efficiencies, and universally accepted data.
• Operational Optimization: Uses case studies to highlight strategies for accelerating timelines, optimizing study designs, and reducing costs.
• Commercial Success: Illustrates how multi-region early-phase data drives robust partnering, licensing, and subsequent clinical success.
• 早期开发全球化： 探讨生物医药创新企业在国际上开展一期（Phase 1）临床试验的拓展机遇。
• 区域战略优势： 展示澳大利亚等基地的独特优势，包括快速的监管审批通道、高性价比以及全球通用的临床数据。
• 运营层面优化： 运用案例分析，重点阐述加速项目时间线、优化试验设计以及降低成本的有效策略。
• 商业成功助力： 阐明多区域早期临床数据的融合如何强力推动商务合作、品种授权以及后续临床研究的成功。

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。

• Embedding agility into study decision models to intelligently support decentralized and hybrid trial models.
• Creating connected DCT ecosystems to shorten study timelines and reduce overall operational burden.
• Leveraging AI-driven insights to optimize end-to-end patient support and long-term adherence.
• Intelligent Medication Management & Safety Monitoring with smart pillboxes to enable closed-loop medication adherence and safety surveillance.

• 将动态适应嵌入研究决策模型，智能支持去中心化和混合型试验模式。
• 打造互联的 DCT 生态系统，缩短研究周期并降低整体运营负担。
• 利用 AI 驱动洞察，优化端到端患者支持和长期依从性。
• 通过智能药盒实现智能用药管理与安全监测，形成闭环用药依从性和安全监测。

Forcing a single clinical supply model across APAC creates delays, costs, and regulatory risks. This presentation addresses regional complexities through flexible strategies and local collaboration.

• Model Selection: Evaluating central, regional, and hybrid supply frameworks.
• Streamlined Logistics: Bridging gaps between sourcing, compliance, and local distribution.
• Risk Mitigation: Overcoming cross-border bottlenecks and critical documentation challenges.
• Strategic Value: Balancing speed, cost, and long-term partner alignment over transactional relationships.

在亚太地区强推单一的临床供应链模型会导致延误、高昂成本和合规风险。本演讲将通过灵活的战略与本地化合作，探讨并解决这些区域复杂性问题。

• 模式选择：评估集中式、区域式以及混合式的供应链架构。
• 高效物流：消除采购、合规与本地分销之间的断层。
• 风险缓解：克服跨境瓶颈与关键文件审查带来的挑战。
• 战略价值：权衡速度与成本，建立长期的伙伴协作，而非单纯的业务交易

• Development of the biomedical industry in SIP
• Innovation ecosystem for biomedical industry in SIP
• 苏州工业园区（SIP）生物医药产业的发展历程与现状
• 苏州工业园区（SIP）生物医药产业的创新生态系统