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MDICx: Clinical Dx Surrogate Sample Harmonized Education Release

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MDICx Webinar

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MDICx Series: Clinical Dx Surrogate Sample Harmonized Education Release

Surrogate Samples, when properly used, decrease the time needed for analytical testing and reduce costs for in vitro diagnostic (IVD) test development and regulatory submission. The Surrogate Sample Framework was released in September 2017 to support innovation as well as provide a predictable path when using surrogate samples for IVD regulatory submissions. The Surrogate Sample Framework is available for download here:

http://mdic.org/clinicaldx/surrogate-sample-framework/

Since its release, the Framework has been accepted by the Clinical and Laboratory Standards Institute to go through the process of becoming an international standard; EP:39 Surrogate Sample Framework is expected publication of the standard is October 2020.

After completing the Surrogate Sample Framework, the working group developed a comprehensive set of educational materials to facilitate FDA reviewers and IVD test developers sharing terminology and principles for acceptable use of surrogate samples. The educational video modules will be available for viewing on the MDIC website.

MDICx Webinar

Thursday, June 27, 12:00 p.m. Eastern / 11:00 a.m. Central / 9:00 a.m. Pacific

Speakers:

April Veoukas, JD | Director, Regulatory Affiars, Strategic Regulatory Affairs, Abbott Quality & Regulatory | Abbott | MDIC Surrogate Samples Working Group Chair,

Marina Kondratovich, PhD | Associate Director for Clinical Studies, Office of Invitro Diagnostics and Radiological Health, CDRH, FDA


*By attending the MDICx Series, you are interested in learning information about MDIC, it's projects and endeavors and agree to receive our e-newsletter updates.

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