DIA 2013 49th Annual Meeting
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US and EU Regulatory Update of Clinical Trial Disclosure
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 254
Date: Tuesday, June 25, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 254AB
CHAIR :
 Barbara Godlew, RN (SCHNON), President, The FAIRE Company, LLC, United States
SPEAKER (S):
 Rebecca J. Williams, PharmD,MPH (SPKAGY), Assistant Director, ClinicalTrials.gov, National Library of Medicine, National Institutes of Health (NIH), United States
 Fergus Sweeney, PhD (SPKAGY), Head of Sector, Compliance and Inspection, European Medicines Agency, European Union, United Kingdom
Description
This session focuses on US and EU requirements for clinical trial disclosure, including results reporting. Information obtained during this session applies to regulatory, clinical operations, medical writing, patient advocacy and other areas.