How to Overcome EU IVDR Challenges when Utilising Clinical Trial Assays to Accelerate Global CDx Trials

Time: 11:55 am
day: Day Two Track C

Details:

  • Challenges associated with the EU IVDR regulation
  • Solutions to help overcome some IVDR hurdles for Global Clinical Trials
  • Key considerations when planning for CDx trials with EU sites
  • Where to look for key information required for CPS submissions
  • EU Country-Specific Regulatory Intelligence

Speakers: