Webinar

Live Webinar | Overcoming regulatory challenges for Companion Diagnostic in Pharma studies

July 02, 2025

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.

Who should attend the webinar?

  • 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

Kristiane Schmidt, PhD
Lorry Weaver, MT(ASCP), CLS(NCA)
Post date: May 23, 2025
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