Kate Simon
Senior Director, Global Regulatory Strategy IVD Bayer
Seminars
Wednesday 1st April 2026
Evolving IVD Regulatory Requirements & the Future of Precision Medicine
12:20 pm
- This presentation will consider how evolving, and at times conflicting, global regulatory policy in key markets such as EU, US and Japan may interplay to impact the future of precision medicine
- The current IVD regulatory landscape in the EU under IVDR, the COMBINE project, as well as the rescission of FDA’s Final Rule on laboratory developed tests in the US will be considered
- Design considerations for implementing CDx testing strategies for early and late phase global precision medicine clinical trials in light of these evolving requirements will be discussed
