TL31: The Impact of EU Post-Approval Safety Surveillance Studies (PASS)
*Charles L Liss, AstraZeneca Pharmaceuticals Keywords: Epidemiology, drug utilization, safety outcomes, off-label use Post Approval Safety Surveillance (PASS) studies required by the EMA as a requirement for product approval are becoming more ubiquitous as the effect of recent legislation is being implemented. Extensive programs of PASS studies are being conducted and results submitted to all regulatory agencies including the FDA. This roundtable would, hopefully, provide some insight into the FDA's view of this data and provide a forum for representatives from various companies to share their experiences in meeting the EMA requirements.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC