Post-Authorization Safety Studies (PASS): progress to date and projections for 2017
Our quarterly Special Report from experts at QuintilesIMS provides scientific and practical insights on Post Authorization Safety Studies based on the first three years since implementation of the new European Union legislation, offering forecasts for likely advances in 2017.
Since the new European Union pharmacovigilance legislation – involving directive 2010/84/EU and regulation 1235/2010 – came into effect in July 2012, large amounts of data from Post Authorization Safety Studies (PASS) have entered the public domain.
Such studies are carried out after a medicine has been authorized, to obtain further information on its safety or to measure the effectiveness of risk-management measures. The available information covers regulatory, methodological and operational considerations for PASS.
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