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Update on the Pilot Process for Biomarker Qualification at the FDA and EMEA

15 May 2008, United States


Introduction
The FDA and the EMEA are testing a Pilot Process for Biomarker Qualification, which was created based on the specific need for new biomarkers in drug development. This Pilot Process needs to be tested and refined with multiple qualification proposals.

Several representatives will be on hand to answer your specific questions and requests for clarification about biomarker qualifications. To help us to properly prepare for this question and answer period, we request that registrants submit their questions in advance to Biomarkerwebinarquestions@diahome.org.

Registrants will also have the opportunity to submit questions during the webinar through an anonymous computerized Q&A function.

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Online, United States

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Drug Information Association
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