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Home » EMA: QMS, AE Reporting Top 2014 Postmarketing Inspection Deviations
EMA: QMS, AE Reporting Top 2014 Postmarketing Inspection Deviations
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year, with 18 sites cited for QMS issues and 13 for AE reporting.
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