Kirsten Van Garsse
Director Authorised Representative Services & Manager IVD - Regulatory Affairs QbD Group
Seminars
Tuesday 31st March 2026
Grey Zones & Growing Pains: The Realities of Pharma–Dx Collaboration
5:20 pm
- 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?
