Rolf Thermann
Section manager TUV Rheinland
Dr. Rolf Thermann is a section manager and TUVs leading Expert for Companion Diagnostics (CDx). Prior to joining TUV Rheinland, Dr. Thermann spent over 10 years in the Pharmaceutical and IVD industries in various leading roles on product development, including CDx products.
Seminars
Tuesday 31st March 2026
Panel Discussion: Defining a Unified Path Towards IVDR Compliance for Streamlined Approvals
5:20 pm
- How has IVDR changed expectations for evidence generation, documentation, and timelines across regulators, notified bodies, pharma, and diagnostic developers?
- Is there any strategy change in aligning with notified bodies and regulators?
- What are the most common bottlenecks companies encounter during co-development; from clinical trials to MAA and conformity assessment?
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
