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Home » QMS, AE Reporting Deviations Flagged Most in EU Postmarketing Inspections
QMS, AE Reporting Deviations Flagged Most in EU Postmarketing Inspections
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year: 18 sites were cited for QMS issues and 13 for problems with AE reporting.