Archives: Agenda

• Building Cross-Functional Leadership: Developing “T-shaped” talent with end-to-end operational vision.
• Proactive Risk Management: Systematically anticipating and mitigating clinical trial risks.
• Strategic Partnership with CROs: Redefining sponsor-CRO collaboration beyond transactional outsourcing.
• From Trial Data to Market Value: Making clinical quality the cornerstone of biotech IPO credibility.

• 构建跨职能领导力： 培养具备端到端（全流程）运营视野的“T型”复合型人才。
• 前瞻性风险管理： 系统性地预测并缓解临床试验过程中的潜在风险。
• 与 CRO 的战略合作伙伴关系： 重新定义申办方与 CRO 的合作模式，摆脱单纯的“交易型外包“。
• 从试验数据到市场价值： 让临床质量成为生物医药企业 IPO（上市）公信力的基石。

• Embedding resilience into supply chain strategy, operations, and quality systems
• Leveraging digital technologies and data visibility to anticipate and mitigate disruptions
• Strengthening supplier networks and risk management frameworks for long-term continuity
• Balancing agility, compliance, and efficiency in an evolving global landscape

• 供应链战略、运营和质量体系的风险管控。
• 利用数字技术与数据可视化提前识别并缓解中断风险。
• 强化供应商网络与风险管理框架，保障弹性供应能力。
• 在不断演变的全球格局中平衡便利性、合规性和效率。

Patient enrollment remains one of the most critical bottlenecks in global drug development, often delaying timelines, increasing costs, and limiting patient access to innovative therapies. Against this backdrop, China has emerged not merely as a region of vast patient numbers, but as a laboratory for systemic innovation in clinical trial execution.  患者入组仍是全球药物开发中最关键的瓶颈之一，常常导致时间线延误、成本上涨，而且还会限制患者获得创新疗法的机会。在这一背景下，中国利用其庞大的患者数量而，不断发展临床试验执行中的体系创新。

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData

• 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）

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。

（请至少参观3个展位）

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