Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician's Perspective.
Background: European legislation requires Marketing Authorization Holders (MAHs) to continuously monitor Eudravigilance (EV) data and inform the European Medicines Agency and national competent authorities of validated safety signals. The process follows the Good Pharmacovigilance Practice Module IX...
| Published in: | Therapeutic Innovation & Regulatory Science Vol. 60; no. 1; pp. 285 - 293 |
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| Format: | research tables/charts Journal Article |
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Springer Nature
Jan2026
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| Online Access: | View this record in EBSCOhost |