Date: 2 July 2025
Time: 16:00h - 17:00h CET
Location: Virtual
Language: English
Introduction
This webinar
will discuss regulatory requirements for using Clinical Trial Assays and
Companion Diagnostics in pharmaceutical clinical studies and share best
practices for overcoming typical challenges.
The webinar consists of a 45-minute presentation and a live Q&A. Questions for the Q&A session can be sent in through the registration form, by email at marketing@qservegroup.com or during the webinar.
Learning Objectives
- Understand the regulatory requirements for using Clinical Trial Assays and Companion Diagnostic in pharma Clinical Trials in the EU and US.
- Identify key considerations for CDx development pathways Companion Diagnostics, selection of diagnostic partners and use of in-house tests/LDTs.
- Learn about best practices for combined studies and coordination between IVD manufacturers and pharma companies.
- IVD and pharmaceutical manufacturers developing Clinical Trial Assays and CDx
- Regulatory Affairs professionals working with Clinical Trial Assays and CDx
- Clinical trial sponsors and CROs involved in combined studies and pharma studies using Clinical Trial Assays and CDx
- Professionals responsible for coordinating clinical study submissions
Qserve Speakers