Post-market Drug Safety Monitoring in the Age of Big Data
View Presentation *Robert Ball, FDA/CDER Keywords: pharmacovigilance, observational data, pharmacoepidemiology This talk will provide an overview of the types of Big Data FDA CDER uses for post-market drug safety monitoring and the need for careful selection of analysis methods based on these data sources. The talk will also touch on new Big Data streams being evaluated and their potential roles in post-market drug safety monitoring.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC