Overview
The on demand webinar recording is approximately 1 hour long, available in Portuguese only.
Periodic benefit-risk evaluation reports (PBRERs) were introduced in 2012 as part of the pharmacovigilance legislation regulation. The E2D Guideline was developed by the ICH Expert Working Group and was adopted by the European Union, Japan, and the USA. Shortly, the Brazilian Health Authority will adopt these guidelines with its agreement to harmonize to ICH standards by 2021.
How will this change increase transparency and allow for an improved benefit-risk profile for a medicinal product throughout its lifecycle. How will the PBER compare to the Periodic Safety Update Report (PSUR) and what changes will there be?
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