Jörg Engelbergs
Scientific-Regulatory Assessor Targeted & Personalized Biomedicines Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices
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?
Wednesday 1st April 2026
Co-Development of Biomarker Guided Medicines, Corresponding Assays & CDx in the EU – A Scientific- Regulatory Update from the Medicine’s Perspective
2:20 pm
- News on the European regulatory framework for biomarker-guided medicines and CDx
- Current experiences and challenges to streamline co-development
- Updates from the EU COMBINE Project
