Exploring the Implications of Companion Diagnostics on Gene Therapy Clinical Trials
Time: 9:30 am
day: Conference Day One
Details:
- 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
