Post-Authorization Safety/Effectiveness Studies (PASS/PAES)
The new EU pharmacovigilance legislation, implemented in 2012, introduced clear rules for Post-Authorization Safety/Effectiveness Studies (PASS/PAES). Post-authorization safety studies are carried out after a drug has been authorized to obtain further information regarding its safety or to measure the effectiveness of risk minimization measures.
These studies could be voluntary or imposed to market authorization holders by the European Medicines Agency (EMA). In this case, the Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols and results of these studies.
We have been successful in getting PRAC approval for our PASS studies. Other regulatory agencies are following in this footsteps as they are also increasingly requiring PASS. A challenge is to adapt a global PASS protocol to meet local requirements and conditions.
Our previous experience in developing study protocols complying with the highest methodological standards, including the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and ISPE GPP, will ensure you the development of studies aligned with the new legislation and PRAC requirements for approval and reporting process.