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  1. News & Events for Human Drugs

Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop

 

FDA and the Biomarkers Consortium Announce a 2-Day Workshop on Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification
 
April 14-15, 2016
Bethesda, Maryland
 
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in co-sponsorship with the Foundation for the National Institutes of Health Biomarkers Consortium, is announcing a public meeting entitled Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop. Biomarker qualification is gaining increased attention across a wide spectrum of stakeholders. This workshop is aimed at creating alignment among scientific stakeholders including FDA, NIH, the biopharmaceutical industry, academic researchers, and patient groups regarding a proposed framework for determining the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on biomarkers used in determinations of drug safety assessments. We will elaborate a general framework for biomarker qualification along with specific application to different contexts of use (COUs) related to drug safety, including assessment of several specific case studies involving qualifying clinical markers of toxicity in different organ systems.
 
When: Thursday April 14 from 9AM- 5PM and Friday, April 15 from 8AM-4PM
 
Where: Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, Bethesda, Maryland
 
Register Now: There is no fee to attend the meeting, but attendees must register in advance. Space is limited, and registration will be on a first-come, first-served basis. Persons interested in attending this meeting must register online at www.fnih.org/evidentiarystandardsworkshop by April 1, 2016.
 
Additional questions? Contact: Janelle Lewis at the Foundation for the NIH (jlewis@fnih.org)
   
 
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