Periodic Benefit–Risk Evaluation Report: A Review of Changes

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Periodic Benefit–Risk Evaluation Report: A Review of Changes

A periodic benefit–risk evaluation report (PBRER) is a retrospective evaluation document enabling marketing authorisation holders to present the results of a critical analysis of the benefit–risk ratio of a medicinal product. PBRER submission and content requirements changed with the adoption of the...

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Bibliographic Details
Main Authors:	A. R. Titova, N. V. Kosyakina, T. S. Polikarpova, Yu. S. Skorodumova, V. A. Polivanov, K. V. Gorelov
Format:	Article
Language:	Russian
Published:	Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2023-03-01
Series:	Безопасность и риск фармакотерапии
Subjects:	pharmacovigilance medicinal product periodic benefit–risk evaluation report pbrer marketing authorisation holder good pharmacovigilance practice periodic safety update report psur
Online Access:	https://www.risksafety.ru/jour/article/view/357
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