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 (Author), N. V. Kosyakina (Author), T. S. Polikarpova (Author), Yu. S. Skorodumova (Author), V. A. Polivanov (Author), K. V. Gorelov (Author)
Format: Book
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2023-03-01T00:00:00Z.
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3rd Floor Main Library

Holdings details from 3rd Floor Main Library
Call Number: A1234.567
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