Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective

In conclusion, significant improvements in the completeness, accuracy, and clinical relevance of ICSRs are essential to support effective safety signal detection and benefit-risk assessment in the post-marketing surveillance of medicinal products.

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Publication Details

Journal
Therapeutic Innovation & Regulatory Science
Published
2025-10-16
DOI
https://doi.org/10.1007/s43441-025-00884-x
Citations
1
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
1.31
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article

Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective

Jana Brajdih Čendak
1 citations
Therapeutic Innovation & Regulatory Science
Pharmacovigilance and Adverse Drug Reactions
1.31
article

Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician’s Perspective

Jana Brajdih Čendak
article en
1 citations

Abstract

In conclusion, significant improvements in the completeness, accuracy, and clinical relevance of ICSRs are essential to support effective safety signal detection and benefit-risk assessment in the post-marketing surveillance of medicinal products.

Therapeutic Innovation & Regulatory ScienceVol. 60(1)
Community Health Centre Ljubljana (SI)
Openalex Percentile: Top 18%
Pharmacovigilance and Adverse Drug Reactions
1.31
DOIOpen Access PDFOpenAlex
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