Archives: Agenda

Quality Management: Maintaining GMP Standards Across Complex Supply Networks 质量管理：在复杂供应网络中维护GMP标准

Ensuring end-to-end compliance with Good Manufacturing Practice (GMP) standards is arguably the most significant operational challenge for sponsors and CDMOs alike. This complexity is heightened by the reality that a clinical supply network being a potential point of failure, not only for product quality but for the integrity of the entire trial.

  • Rethinking the Role of the Quality Unit
  • Risk-Based Supplier Qualification and Lifecycle Management
  • Digital Platforms for End-to-End Quality Data Integrity
  • Managing Change in a Distributed Network
  • Building a Culture of Quality Across Organizational Boundaries

确保端到端合规、始终遵循药品生产质量管理规范（GMP），或许是申办方与CDMO共同面对的最大运营挑战。更棘手的是，临床供应网络的任何一环出现纰漏，不仅可能危及产品质量，更可能动摇整项试验的数据完整性。

  • 质量部门的角色需要重新定义
  • 基于风险的供应商资格认定与全生命周期管理
  • 端到端质量数据完整性的数字化平台支撑
  • 分布式网络下的变更如何管理
  • 跨越组织边界的质量文化建设

Dynamic Forecasting for Rapidly Enrolling Trials 快速入组试验的动态预测

Exploring agile forecasting strategies that enable clinical supply teams to respond in real time to fast recruitment rates, minimising risk, waste, and patient disruption.

  • Why Speed Creates a New Breed of Supply Chain Risk
  • How to Leverage Real-Time Enrollment Analytics and Site Intelligence
  • From Flexible Packaging to Just-in-Time Manufacturing
  • The Regulatory-Planning Nexus: Aligning with China’s Accelerated Pathways
  • How to build Collaborative Ecosystem Orchestration

中国无与伦比的患者招募速度，已将其推升为临床试验不可或缺的加速引擎。然而，那些建立在线性假设与滞后数据之上的传统需求预测模型，在中国临床生态的动态现实面前不堪一击。

  • 速度为何催生全新供应链风险
  • 如何活用实时入组数据与中心情报
  • 从柔性包装到即时生产
  • 监管与计划的交汇点：对齐中国加速审批路径
  • 如何构建协同生态的全局调度能力

Comparator Sourcing: Navigating Global Supply for China Registration Trials 对照药采购：为中国注册临床试验导航全球供应链

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.

  • Why Compliance is Non-Negotiable
  • From Global Market to Local Solutions
  • Mastering the Logistics & Regulatory Journey
  • How to ensure Supply Continuity
  • What is the Evolving Landscape in the Future

在中国注册临床试验的筹备过程中，寻获合适的对照药往往是最关键却又最棘手的关卡。与其它试验物资不同，对照药远非普通商品——它是监管审评的标尺，是临床设计的刚需，更是随时可能拖垮进度、危及数据完整性的潜在瓶颈。

  • 从全球采购到本土化解决方案
  • 通关物流与法规路径的全流程掌控
  • 如何确保供应不间断
  • 未来格局将如何演变

PANEL DISCUSSION: Platform Strategies: Designing Flexible Supply Chains for Multi-Modality Trials 圆桌讨论：平台化战略——为多疗法组合试验设计柔性供应链

A single biopharma portfolio today may encompass a diverse mix of modalities—small molecules, monoclonal antibodies, ADCs, cell therapies, and more—each with vastly different and often contradictory supply chain requirements. This new reality demands a fundamental shift towards platform-based supply chain strategies.

  • What Are We Actually Building?
  • Orchestrating Complexity with Data & AI
  • From Transactional Vendors to Strategic Capability Partners
  • Upskilling Teams for a Multi-Modality World
  • How to Measure Success?

当今一个生物医药研发管线往往涵盖小分子、单抗、ADC、细胞疗法等多种药物类型，彼此的供应链要求差异巨大，甚至相互矛盾。这一新常态倒逼行业向“平台化供应链”战略根本转型。

  • 我们到底在搭建什么？
  • 用数据与人工智能调度复杂系统
  • 从“买卖供应商”到“战略能力合伙人”
  • 为多疗法时代重塑团队能力
  • 成功的衡量标准