Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project-Reference-Cited by-同舟云学术

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Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

Published:2024-01-06 Issue:3 Volume:47 Page:261-270
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

van Rijt-Weetink Yrea R. J.^ORCID,Egberts Toine C. G.^ORCID,van Hunsel Florence P. A. M.^ORCID,Lewis David J.^ORCID,Yates Laura M.^ORCID,Winterfeld Ursula^ORCID,van Puijenbroek Eugène P.^ORCID

Funder

Innovative Medicines Initiative 2

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s40264-023-01389-y.pdf

Reference21 articles.

1. Benevent J, Montastruc F, Damase-Michel C. The importance of pharmacoepidemiology in pregnancy-implications for safety. Expert Opin Drug Saf. 2017;16(10):1181–90.

2. Bergvall T, Norén GN, Lindquist M. VigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf. 2014;37(1):65–77.

3. European Medicines Agency. EudraVigilance. https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance. Accessed 15 Nov 2023.

4. European Network of Teratology Information Services. ENTIS. https://www.entis-org.eu/. Accessed 15 Nov 2023.

5. Geissbühler Y, Rezaallah B, Moore A. An alternative to product-specific pregnancy registries? PRIM PRegnancy outcomes Intensive Monitoring. Reprod Toxicol. 2020;94:13–21.

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