Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice
Author:
Affiliation:
1. Scientific Centre for Expert Evaluation of Medicinal Products
Publisher
SCEEMP
Subject
General Medicine
Reference8 articles.
1. Peters T, Soanes N, Abbas M, Ahmad J, Delumeau JC, Herrero-Martinez E, et al. Effective pharmacovigilance system development: EFPIA-IPVG consensus recommendations. Drug Saf. 2021;44(1):17–28. https://doi.org/10.1007/s40264-020-01008-0
2. Lavery C, Emmott J, Jeck-Thole S, Rouben P, Usher D, van der Spuij W, Woodward L. An industry survey on managing the pharmacovigilance system master file in a global environment: the need for a pragmatic approach. Pharmaceut Med. 2022;36(4):233–45. https://doi.org/10.1007/s40290-022-00422-2
3. Rocca E, Copeland S, Ralph Edwards I. Pharmacovigilance as scientific discovery: an argument for trans-disciplinarity. Drug Saf. 2019;42(10): 1115–24. https://doi.org/10.1007/s40264-019-00826-1
4. Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf. 2017;40(10):855–69. https://doi.org/10.1007/s40264-017-0572-8
5. Gildeeva GN, Belostotsky AV. Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU. PHARMACOECONOMICS. Modern Pharmacoeconomics and Pharmacoepidemiology. 2019;12(2):86–90 (In Russ.). https://doi.org/10.17749/2070-4909.2019.12.2.86-90
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