Periodic Benefit-Risk Evaluation Report: A Review of Changes

• 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.
• Subjects: article
• Online Access: Connect to this object online.

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...