Archives: Agenda

Securing the right comparator drug is often the most critical yet daunting hurdle in planning a registration trial in China. Unlike other supplies, a comparator is not merely a commodity; it is a regulatory benchmark, a clinical necessity, and a potential bottleneck that can derail timelines and compromise data integrity.

• Strategies to ensure unbroken supply continuity.
• Risk mitigation plans for sourcing uncertainties.
• Practical insights from global pharmaceutical business.

在筹备中国注册临床试验的过程中，获取正确的对照药往往是最关键但也最棘手的难题。与其他临床供应品不同，对照药不仅仅是一种物资，它更是监管的基准、临床的必需品，也是一个极易导致项目延期并损害数据完整性的潜在瓶颈。

• 保障供应链持续不中断的应对策略
• 针对采购不确定性的风险缓解计划
• 来自全球制药企业的实用洞察

• 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。

• Understanding country-specific site application and approval requirements
• Reducing start-up timelines through effective planning and local partnerships
• Common challenges and pitfalls when activating sites across multiple regions
• Best practices for successful collaboration with investigators, sites, and regulators

• 了解各国特定的中心申请与审批要求。
• 通过有效规划和本地合作伙伴关系缩短启动时间。
• 跨多个区域启动中心时常见的挑战和陷阱。
• 与研究者、中心和监管方成功协作的最佳实践

Moderator:

Julia Leng Multitude Therapeutics