Speakers
Host
Kirsten Van Garsse
Guest
Annelies Rotthier
The Sponsor's Survival Guide
This podcast episode focuses on the challenges IVD sponsors face, particularly around collaboration in combined studies, and shares practical insights to help navigate these complex projects.
What you'll learn
- The key challenges IVD sponsors face in clinical trials
- How to navigate collaboration in combined studies
- Practical insights for managing complex IVD projects
- Understanding IVDR requirements for clinical performance studies
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
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.
About the Author
15 years of experience in IVD field · Business Unit Manager IVD CRO
IVD Clinical Evidence and Medical Writing. IVD Product Development and IVDR Compliance. Strategic leadership & Consultancy.
Accelerate Your Clinical Programs
End-to-end clinical trial management from strategy to submission for medical devices, IVD, and pharmaceuticals.
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