Regulatory Pathways for Diagnostic Tests in the United States and Europe

Online Seminar

12 September 2023 - 12 September 2023

Date: 12 September 2023 | 4 p.m. - 5 p.m. CEST (Amsterdam, Berlin, Paris)

Registration is free of charge: Link

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.

4:00 p.m. | Opening Remarks

  • Edward Abrahams, President, Personalized Medicine Coalition
  • Antonio L. Andreu, Scientific Director, EATRIS
  • Margot Jehle, Project Leader, Codex4SMEs

4:10 p.m. | Presentations on Regulatory Pathways for Diagnostic Tests in the United States and Europe

  • Joseph V. Ferrara, Chief Strategy Officer, Veranex
  • Sheila Walcoff, Esq., CEO, Goldbug Strategies

4:50 p.m. | Answers to Questions Submitted Via Private Chat Function

  • Moderated by Christopher J. Wells, Senior Vice President, Public Affairs, Personalized Medicine Coalition

5:10 p.m. | Closing Remarks/Display Speaker Contact Details

  • Margot Jehle, Project Leader, Codex4SMEs



The Webinar will be recorded.

Virtual Tutorial Flyer

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