---
title: "Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space"
description: "Join Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD manufacturers."
url: https://qbdgroup.com/en/webinars/navigating-grey-zones-growing-pains-regulatory-cdx-space
type: "Webinar"
language: en
published: 2026-03-17
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space\", https://qbdgroup.com/en/webinars/navigating-grey-zones-growing-pains-regulatory-cdx-space"
---
# Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space
> Join Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD manufacturers.

## About this webinar

The tremendous advances in the Precision Medicine field are shifting the focus of treatment towards more precise and targeted treatments that leverage intrinsic features of the immune system. As the genetic background of the patient and/or disease determines the efficacy of such therapies, there is a growing need for companion diagnostics (CDx).

The co-development of a CDx between Pharma and IVD manufacturers comes with its own Grey Zones and Growing Pains, with differing regulations, submission processes, and different understanding of the roles and responsibilities. These challenges also offer opportunities to improve the ways of working and increase partnership effectiveness.

## What you will learn

During this webinar, **Kirsten van Garsse** (QbD Group) and **Jules Petit** (GenDx) will discuss key elements of their joint panel discussion at the **16th World Clinical Biomarkers & Companion Diagnostics Summit Europe** and dive deeper into the regulatory impact of current developments and trends in the Companion Diagnostics space.

- Key regulatory developments shaping the CDx landscape
- Grey zones in the co-development of CDx between Pharma and IVD manufacturers
- How differing regulations and submission processes impact partnerships
- Opportunities to improve collaboration and partnership effectiveness

## Interactive Q&A

During the live webinar, we would like to answer your questions regarding the regulatory CDx space. You are invited to submit questions during registration or live during the session.

## Speakers

Meet the experts leading this session.

![Kirsten Van Garsse](speaker)
#### Kirsten Van Garsse
Business Unit Manager RA IVD & Representative Services, QbD Group
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.

![Jules Petit](speaker)
#### Jules Petit
PhD | Project Manager CDx, GenDx
Jules Petit is a regulatory and scientific expert at GenDx, contributing to advancements in companion diagnostics and precision medicine through cross-industry collaboration.

## Who should attend

This webinar is ideal for professionals working in the CDx and precision medicine space.

- Regulatory Affairs professionals in IVD and Pharma
- CDx development and program managers
- Quality and compliance leaders in diagnostics
- Business development professionals in precision medicine
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Source: https://qbdgroup.com/en/webinars/navigating-grey-zones-growing-pains-regulatory-cdx-space — © QbD Group. Quote freely with attribution and a link back.