Lindsey Bennie

Company: ARC Regulatory

Job title: Laboratory Manager

Seminars:

Overcoming IVDR Compliance Challenges in Early Clinical Development 4:25 pm

IVDR requires robust scientific validity, analytical performance, and clinical performance data, with pharma sponsors now needing to conduct a performance study in parallel to their phase I/II clinical trial in all EU member states participating in the IMP trial This more complex technical package is coupled with an expanded documentation file per device and subsequently…Read more

day: Day 1 - Track B (2)