Traingle CERSI: Advancing Novel Surrogate Endpoints for Rare Disease Drug Development
Workshop: Advancing Novel Surrogate Endpoints for Rare Disease Drug Development
The Triangle Center of Excellence in Regulatory Science & Innovation (Triangle CERSI) invites you to join FDA, researchers, clinicians, and innovators for a free, one-day virtual workshop open to the public focused on emerging scientific and regulatory pathways for advancing surrogate endpoints in rare disease drug development.
This workshop is being convened in support of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, established under the FDA User Fee Reauthorization Act of 2022 and the Food and Drug Omnibus Reform Act of 2022. The RDEA program is intended to support the development of efficacy endpoints for rare disease treatments by fostering dialogue among FDA, researchers, clinicians, industry, patient communities, and other stakeholders.
Triangle CERSI is partnering with the UNC School of Medicine to offer ACCME-based continuing medical education credit.