Jai Pandey
Head, Global Device Regulatory for IVDs & Digital Health Sanofi
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?
