Periodic Benefit–Risk Evaluation Report: A Review of Changes

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

Internet

https://www.risksafety.ru/jour/article/view/357

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