PANEL DISCUSSION: Overview of Clinical Trial in Sites Application Overseas 圆桌讨论:海外临床试验中心申请全景洞察

  • How to Select the Strategic Country & Site
  • Decoding the Global Regulatory Map: Centralized Systems vs. National Labyrinths
  • Separating Marketing from Reality
  • Mastering the Institutional Labyrinth: From PI to Signed Contract
  • Building a Future-Proof Strategy: Alignment with ICH E6(R3) and Global INDs
  • 如何选定战略性国家与研究中心
  • 解码全球监管版图:集中审评体系 各国准入体系
  • 祛魅营销话术,直面落地现实
  • 攻克机构壁垒:从主要研究者到合同签署
  • 构建未来可延展的战略:对齐 ICH E6(R3) 与全球临床试验申请申报要求

Strategic Site Selection for Globalizing Chinese Innovators 智能试验设计:借力真实世界证据优化中国临床试验

  • Leveraging Regulatory Bridgeheads: The Australia Acceleration Model
  • Orchestrating Asia-Pacific Networks for Scale and Speed
  • The Art of China-Global Synchronization
  • Integrating Technology to Create New Ecosystems
  • 基于真实世界患者旅程预测入组节奏
  • 科学严谨性与外部推演性的天平如何平衡
  • 终点优化与对照药选择依据:构建一个有说服力的逻辑闭环
  • 如何为混合型、实效型及外部对照臂试验提供支持
  • 真实世界数据如何接入方案整合流程

Beyond Oncology: Showcasing China’s Global-Ready Pipelines in Immunology & Metabolic Diseases 不止于肿瘤:中国免疫与代谢领域的全球级管线正在崛起

  • The Antibody Platform Advantage: Engineered for Immunology
  • Metabolic Disease Breakthroughs: From Fast Follower to Innovator
  • Global Validation Through Partnership & Capital
  • Pipeline Maturity: From Early Promise to Late-Stage Reality
  • The Strategic Infrastructure for Globalization
  • 抗体平台的优势迁移:为免疫学科身定制
  • 代谢疾病的创新突围:从快速跟跑到全球首发
  • 资本与合作的双重背书:全球化价值验证
  • 成熟管线路径:从早期概念到后期现实
  • 支撑全球化的战略基础设施

Intelligent Trial Design: Leveraging Real-World Evidence to Optimize Clinical Trials in China 中国创新药企全球化中心战略选址

  • Predicting Enrollment with Real-World Patient Journeys Balancing Scientific Rigor with Generalizability
  • Endpoint Optimization & Comparator Justification: Building a Persuasive Rationale
  • How to Support Hybrid, Pragmatic, and External Control Arm Trials
  • Access to Protocol Integration

 

  • 借力监管“桥头堡”:澳大利亚加速模式
  • 亚太临床网络的规模化与提速协同
  • 中国与全球同步开发的策略艺术
  • 技术赋能,打造新生态