Kate Simon
Senior Director, Global Regulatory Strategy IVD Bayer
Kate Simon is a Senior Director, Global Regulatory Leader at Bayer with over 20 years of experience in IVD and companion diagnostic (CDx) regulatory affairs. Before joining Bayer, she was a Director, Global Regulatory Affairs, IVD at GSK where she supported multiple global CDx development efforts; Kate has also worked at QIAGEN where she led companion diagnostic regulatory strategy from the diagnostic perspective. Prior to joining industry, she worked 11 years in the Office of In Vitro Diagnostics at FDA/CDRH during which time she served as a Master Reviewer and an instructor to industry on premarket IVD submissions.
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
