Glossary Term

PBRER

Periodic Benefit-Risk Evaluation Report (PBRER) is the ICH-harmonised format for periodic safety reporting, replacing the PSUR in many markets and providing a structured benefit-risk assessment of authorised medicines.

Illustration representing PBRER
Listen to definition
Related terms
PSUR GVP PV
Further reading
EMA: PBRER Browse the HEOR resource database

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