Kirsten Van Garsse
Director Authorised Representative Services & Manager IVD - Regulatory Affairs QbD Group
Kirsten Van Garsse holds a master’s degree in biomedical sciences and brings over 20 years of leadership experience in the In Vitro Diagnostic (IVD) industry.
Since joining Qarad, now part of the QbD Group, in 2017, Kirsten has led the company’s regulatory strategy and compliance initiatives for IVDs. In her dual role as Regulatory Affairs Manager and Authorized Representative Director, she oversees regulatory programs across a broad portfolio of IVDs while managing all representation services offered by the company.
Kirsten’s expertise spans Companion Diagnostics and IVDs from Class A to D. She is particularly recognized for navigating the complex interface between pharmaceuticals and diagnostics, providing strategic, compliant solutions for combined drug–diagnostic development programs. Her experience in aligning regulatory requirements, study timelines, and cross-sector responsibilities makes her a trusted voice on the practical realities of pharma–Dx collaboration.
Seminars
- At what stage should the diagnostic partner ideally be involved to ensure technical and regulatory alignment without slowing drug development?
- What does an ideal collaboration model look like under IVDR, balancing innovation speed with compliance?
- Can pharma use any IVD within its drug trial framework?
- Who should take the lead, and the regulatory accountability, in a combined study?
