Signal Management: Updated Requirements of the EAEU Good Pharmacovigilance Practice-Reference-Cited by-同舟云学术

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Signal Management: Updated Requirements of the EAEU Good Pharmacovigilance Practice

Published:2023-02-15 Issue:1 Volume:11 Page:38-45
ISSN:2619-1164
Container-title:Safety and Risk of Pharmacotherapy
language:
Short-container-title:Bezopasnost' i risk farmakoterapii

Author:

Matveev A. V.¹^ORCID,Krasheninnikov A. E.²^ORCID,Zelinskaya A. Yu.³^ORCID

Affiliation:

1. National Pharmacovigilance Research Center; Russian Medical Academy of Continuous Professional Education

2. National Pharmacovigilance Research Center; N.I. Pirogov Russian National Research Medical University

3. National Pharmacovigilance Research Center

Publisher

SCEEMP

Subject

General Medicine

Reference5 articles.

1. Matveev AV, Krasheninnikov AE, Matveeva EA, Romanov BK. Differences between the European and Eurasian Good Pharmacovigilance Practices. Safety and Risk of Pharmacotherapy. 2021;9(2):75–84 (In Russ.). https://doi.org/10.30895/2312-7821-2021-9-2-75-84

2. Kolbin AS, ed. Pharmacovigilance. Moscow: OKI; 2019. (In Russ.).

3. Radecka A, Loughlin L, Foy M, de Ferraz Guimaraes MV, Sarinic VM, Di Giusti MD, et al. Enhancing pharmacovigilance capabilities in the EU regulatory network: the SCOPE joint action. Drug Saf. 2018;41(12):1285–302. https://doi.org/10.1007/s40264-018-0708-5

4. Caster O, Aoki Y, Gattepaille LM, Grundmark B. Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations. Drug Saf. 2020;43(5):479–87. https://doi.org/10.1007/s40264-020-00911-w

5. Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72(6):905–8. https://doi.org/10.1111/j.1365-2125.2011.04037.x

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