Regulatory Pathways for Diagnostic Tests in the United States and Europe

To help facilitate the efficient regulatory review of a new generation of innovative diagnostics that promise to advance the frontiers of personalized medicine to benefit patients and health systems, PMC, a 501(c)3 nonprofit organization that promotes personalized medicine on behalf of its more than 220 institutional members in the United States and around the world, Codex4SMEs, an Interreg North West Europe funded project and network supporting the development of innovative diagnostics by small and medium-sized companies based in Northwestern Europe and beyond, and the European Infrastructure for Translational Medicine (EATRIS), which is dedicated to supporting the translation of scientific discoveries into medical products, will host a virtual tutorial on September 12 on the regulatory pathways for bringing new diagnostics to market in the United States and Europe.

During the tutorial, experts from Goldbug Strategies, which advises innovative molecular science and digital health technology companies on their business and regulatory strategies, and Veranex, which delivers technology and service solutions to medical technology companies from concept to commercialization, will deliver a 30- to 40-minute presentation before taking questions from an online audience comprised of representatives from PMC, Codex4SMEs, and EATRIS’ member networks.