Custom PSUR Preparation by Diapharm
- Regular literature reviews
- Assessment, evaluation, and processing of suspected adverse drug reactions (ADRs)
- Analysis of company-specific data
- Monitoring submission deadlines according to authorization documents, the Union Reference Dates (EURD) list, and PSUR Work Sharing and Synchronisation Listss
- Preparing the final, submission-ready Periodic Safety Update Report (PSUR)
The requirements for PSURs are defined in the European Guideline on Good Pharmacovigilance Practice (GVP), which is based on the international ICH Guideline E2C for Periodic Benefit-Risk Evaluation Reports (PBRERs). Diapharm’s PSURs fully comply with these standards.
PSURs – available on request
For numerous active pharmaceutical ingredients, Periodic Safety Update Reports (PSURs) are already available.
