Vice President, Regulatory, Clinical and Medical Affair, Illumina Inc.
Mya Thomae is Illumina’s Vice President of Regulatory, Clinical and Medical Affairs. Mya has more than twenty years of experience as a regulatory professional including founding and running Myraqa, a boutique regulatory affairs consulting firm purchased by Illumina in 2014. Mya has extensive experience in gaining regulatory approvals for novel IVDs in the United States and Europe. This work has included PMAs, 510(k)s and de novo 510(k)s in the United States for both kit and lab-based products. In the European Union, Mya has experience with working with Notified Bodies and Competent Authorities on List A, List B and self-certified products. Certified by the Regulatory Affairs Professional Society (RAPS) since 1994, Mya also received the FDA Commissioner’s Special Citation in 2009 as a member of the rRt-PCR Flu Panel Team for exceptional performance and dedication in addressing complex regulatory and scientific issues in the clearance of a CDC test to diagnose human influenza infection.
Through presentations and a panel discussion, industry and legal experts examine regulatory frameworks and updates surrounding cell and gene therapy, diagnostics, and digital health, both in the US and Japan.