PANEL DISCUSSION: The Future of Clinical Trials for China to Overseas: Trends and Predictions 专题讨论:中国临床试验海外机遇与展望

  • The impact of China’s biotech boom on global trials
  • How do the global policies and regulatory difference impact the decision of China biotech
  • The opportunities and challenges for clinical trials overseas and license out.

Moderator:

Xiaoyu Deng, Founder & CEO, MDCE

  • 中国生物科技热潮对全球试验的影响
  • 全球出海政策及监管差异对中国企业选择的决定影响
  • License-out 与海外临床试验的不同机遇与挑战

主持嘉宾:

邓晓宇,创始人,希毅医学

Navigating Licensing & Regulatory Frameworks in China 中国许可与监管框架的应对策略

  • Updates on China’s National Medical Products Administration (NMPA) regulations
  • Recent reforms in drug and device approval processes
  • Best practices for obtaining IND and NDA approvals in China

 

  • 中国国家药品监督管理局(NMPA)法规更新
  • 药品和医疗器械审批流程的最新改革
  • 在中国获得IND(新药临床试验申请)和NDA(新药上市申请)批准的最佳实践