Thursday, 21 February 2019
5:30–8:30 pm EST
Ortho Clinical Diagnostics
1001 North US Route 202
Raritan, NJ 08853
+1 800 828 631
Join regulatory professionals from your local area for an evening of networking and to hear an interactive presentation from an FDA representative on an important topic.
The speaker’s presentation will explore design issues related to analytical studies and how to design precision studies in a more optimal way, including whether the type of assay (either quantitative or qualitative) is important for the study design, and how to use surrogate samples in analytical studies. The speaker will also discuss what additional issues should be considered for the inclusion of archived samples in the clinical performance study. For companion diagnostic devices, bridging studies will be examined as well.
This event, hosted by Ortho Clinical Diagnostics, is brought to you by the New York/New Jersey and is intended to facilitate networking and knowledge sharing among regulatory professionals in the region. A light meal will be available for all attendees and RAC holders may claim two RAC recertification credits.
Dr. Marina V. Kondratovich, PhD, associate director, clinical studies, Office of In Vitro Diagnostic and Radiological, CDRH, FDA
Registration Fees: #NY/NJChapter
RAPS Members: $35