Periodic safety update report (PSUR)

Diapharm prepares periodic safety update reports (PSURs), also known as periodic benefit-risk evaluation reports (PBRERs), for numerous active pharmaceutical ingredients for medicinal products that will continue to require PSURs in the future.

On behalf of our clients, we can prepare PSURs that review scientific literature or evaluate company-specific data on an individual basis and prepare complete, ready-to-submit, customised PSURs for human and veterinary medicinal products.

• Regular literature research in Medline (or further sources, if required)
• Review, evaluation and processing of suspected adverse drug effects (ADRs)
• Analysis of company-specific data
• Monitoring of submission deadlines in line with marketing authorisations, list of EU reference dates (EURD list) and PSUR work sharing and synchronisation lists
• Preparation of a ready-to-submit periodic safety update report (PSUR)

The standards for periodic safety update reports (PSURs) are defined in the European good pharmacovigilance practice (GVP) guidelines, which are based on the international ICH guideline E2C on periodic benefit-risk evaluation reports (PBRER). PSURs from Diapharm meet these standards.