Regulatory Pathways for Diagnostic Tests in the United States and Europe

Date & Time 12 September 2023
Location Virtual Event

To help facilitate the efficient regulatory review of a new generation of innovative diagnostics that promise to advance the frontiers of personalised medicine to benefit patients and health systems, PMC (a nonprofit organisation that promotes personalised medicine on behalf of more than 220 institutional members in the United States and around the world), Codex4SMEs (an inter-regional cooperation network supporting the development of innovative diagnostics by small and medium-sized companies in Northwestern Europe), and EATRIS (which is dedicated to supporting the translation of scientific discoveries into medical products) plan to organise a virtual tutorial in September 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 commercialisation, will deliver a 30- to 40-minute presentation before taking questions from an online audience comprised of leaders from PMC, Codex4SMEs, and EATRIS’ member networks.

Learn more here.

Watch the recording below and download the tutorial slide deck here.