Rolf Thermann
Section Manager IVD & Companion Diagnostics Lead TUV Rheinland
Seminars
Tuesday 31st March 2026
Panel Discussion: Defining a Unified Path Towards IVDR Compliance for Streamlined Approvals
4:50 pm
- How has IVDR changed expectations for evidence generation, documentation, and timelines across regulators, notified bodies, pharma, and diagnostic developers?
- At what stage should pharma and diagnostic partners meaningfully engage notified bodies and regulators to ensure an aligned CDx development pathway? And what does effective early alignment look like?
- What are the most common bottlenecks companies encounter during IVDR certification, and what practical steps or partnership models are proving successful in navigating them?
Tuesday 31st March 2026
Advancing Novel Frameworks for Companion Diagnostics in Europe: Lessons Learned
2:30 pm
- Reviewing the EMA consultation procedure
- Defining the intended Purpose of a CDx, classification
- Discussing the route to compliance
