MDIC has issued an invitation to a workshop to explore key considerations for using Real-World Data (RWD) and Real-World Evidence (RWE) to help support in vitro diagnostic (IVD) products available under FDA's emergency use authorization (EUA) to advance to full marketing status.
The projected outcomes of this workshop include:
- Identify test case(s) of interest to stakeholders
- Discussion to inform development of a roadmap for diagnostic evaluations during emergencies, to include what elements to collect (and how)
- Identify potential projects or next steps for the test case(s) of interest
Keynote Speakers:
- Luciana Borio, MD; Vice President, Technical Staff | In-Q-Tel
- Nira Pollock, MD, PhD; Associate Medical Director of Infectious Diseases Diagnostic Laboratory | Boston Children's Hospital; faculty member of the Division of Infectious Diseases | Beth Israel Deaconess Medical Center
FDA Speakers:
- RADM Denise Hinton, FDA Chief Scientist
- Timothy Stenzel, MD, PhD, Director, OHT7: Office of In Vitro Diagnostics and Radiological Health | CDRH
- Uwe Scherf, M.Sc., PhD, Director, Division of Microbiology Devices, OHT7: Office of In Vitro Diagnostics and Radiological Health | CDRH
https://mdic.org/event/advancing-eua-ivd-products-toward-full-marketing-status/
The meeting will be held on FDA's White Oak Campus. Registration is free.
If anyone knows anyone who has a clue about the subject matter, please pass this along to them.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------