Songmei Xie

National Medical Products Administration (NMPA) China

See Songmei Xie at this event

  • Day 4 Friday 6 December

Advancing clinical trials: The impact of E6(R3) guideline

Session objectives:

  • Comprehend E6(R3) Guideline Revisions: key updates in E6(R3) and their significance for enhancing clinical trial practices and aligning with international standards.
  • Analyze Regulatory Preparations: how different regulatory authorities are preparing for the implementation of E6(R3).
  • Explore Data Integration: Consider the impact of E6(R3) on the use of Real-World Data (RWD) and Real-World Evidence (RWE), including the associated challenges and opportunities.