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

 
  April 09, 2008  
     
 
Drug Information Association, Online
May 15 2008


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.
 
 
Organized by: Drug Information Association
Invited Speakers: 1) Federico Manuel Goodsaid, PhDSenior Staff Scientist, Genomics Group, OCP, OTS, CDERFDAUnited States.  2) Marisa Papaluca-Amati, MDDeputy Head of Sector, Safety and Efficacy of MedicinesEuropean Medicines Agency, European UnionUnited Kingdom.  3) Spiros Vamvakas, Dr. Med, MDActing Deputy Head of Sector, Scientific Advice and Orphan DrugsEuropean Medicines Agency, European UnionUnited Kingdom.
 
Deadline for Abstracts: -
 
Registration: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17117&eventType=Webinar
E-mail: dia@diahome.org
 
   
 
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