Pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.
Glossary
Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
Resources
Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
Glossary
The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.
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