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Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of general strengthening of pharmacovigilance procedures. Interventional PASS will largely adhere to International Conference on Harmonisation requirements, but non-interventional (NI) PASS should be reported according to a particular mandated format,doi:10.1179/2047480614z.000000000253 fatcat:soyd5vf5gjfa7gmdzl5xd53zqi