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A Virtual Tutorial on Regulatory Pathways for Diagnostic Tests in the United States and Europe

September 12, 2023 @ 10:00 am - 11:30 am

–> Watch video recording

–> Download tutorial slide deck

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, the Personalized Medicine Coalition, Codex4SMEs, an inter-regional cooperation network supporting the development of innovative diagnostics by small and medium-sized companies 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, hosted a virtual tutorial on September 12, 2023, 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, delivered a presentation defining the available regulatory pathways before taking questions from an online audience comprised of representatives from PMC, Codex4SMEs, and EATRIS’ member networks.