Anupam Talapatra
Director - Global Regulatory Affairs, Precision Medicine & Companion Diagnostics Gilead Sciences
Seminars
Wednesday 24th September 2025
Navigating Through the Complex Compliance Landscape of Device Performance Study Under IVDR in the Context of an EU Clinical Trial
2:40 pm
- Dependence on the status of the associated drug study
- Patient-centric considerations
- Study sponsorship obligations and oversight responsibilities
- Alignment of all entities involved in the Performance Study ecosystem
