Description: Developing companion diagnostics requires knowledge of medicinal products and in-vitro diagnostic (IVD) medical devices. Drug developers and IVDmanufacturers must work seamlessly together to create combined drug clinical trials and IVD clinical performance study (CPS) applications. These twoexpert groups typically speak different languages and lack knowledge of both medicinal products and IVD regulatory activities. In addition, the newEuropean Regulation 2017/746 also creates additional requirements for in-house test laboratories, which are often included in clinical performancestudies of IVD medical devices. This session will help listeners understand how to develop successful combined drug trial – companion diagnosticsperformance study submissions by answering the following questions: - How should drug clinical trials and IVD performance studies be linked to each other? - What type of data is needed for retrospective and prospective studies? - What data submission and notification packages are needed in the EU? - Are there European country-specific requirements? Knowledge and advice are shared from current experiences conducting combined drug clinical trials and companion diagnostics performance studies.
Learning Objectives:
Describe the relationship between drug clinical trials and the related companion diagnostics' clinical performance studies
Understand the difference between clinical performance study requirements of retrospective studies with left-over samples and prospective studies.
Collect the correct clinical performance study NCA and EC submission files and notification packages to make application process in EU faster
