RADx Tech Webinar
Pooling Overview, Key Development Challenges for Central Laboratories and Point of Care (POC) Solutions, Regulatory Guidance for Pooling, and Implementation Examples
A multi-disciplinary RADx Pooling Task Force has been created to engage with the FDA, CMS, and CDC to address COVID-19 pooling practices and develop guidance for both laboratory and point-of-care (POC) settings. Importantly, there is no existing EUA regulatory guidance for POC pooling, and there are no approved POC pooling solutions available on the market. The presentation will be a high-level overview of COVID-19 pooling with examples, implementation challenges, and regulatory requirements and solutions.
Speaker
Wolfgang Krull
RADx Portfolio Executive & CIMIT Accelerator Executive
Pam Miller
RADx Team Lead
Clair O’Donovan, PhD
RADx Team Lead
Erika A. Tyburski
RADx Regulatory Core & Director of Operations, Atlanta Center for Microsystems Engineered Point of Care Technologies (ACME POCT)
Ethan Burke MD, MP
Chief Public Health Officer UnitedHealth Group
When
June 15, 2021
2:00 pm, ET
RSVP by June 14, 2021