Exploring the Implications of Companion Diagnostics on Gene Therapy Clinical Trials

Time: 9:30 am
day: Conference Day One


  • Understand the key differences to FDA regulations to avoid pitfalls later on in your study pipeline
  • Demystify the In Vitro Diagnostics Regulations (IVDR) to ensure compliance and regulatory requirements are met to obtain necessary approvals and gain access to the EU market
  • Clarifying the differences in emphasis on clinical evidence and risk classification between the IVDR and FDA