PSURs
Periodic Safety Update Reports
PSURs are periodic reports in which the benefit-risk profile of a medicinal product is assessed.
We offer you both the creation of individual PSURs and cross-company, pooled PSURs in the form of PSUR templates according to your company-specific requirements.
The reports are prepared in accordance with GVP module VII and made available in an editable format.
Pooled PSUR
This is an active substance-related PSUR template – this includes, among other things
- Extensive text modules
- Summary tabulations for literature cases
- Published studies
- Bibliography
Individual PSUR
An individual PSUR is prepared by us in accordance with Good Pharmacovigilance Practices (GVP Guideline) and is “ready for submission”, taking into account MAH-specific data.
It includes, among other things:
- Published studies
- Company-specific information (spontaneous registrations, including line listings, summary tabulations and narratives, sales figures, registration data)
- Texts and analyses (including the risk-benefit analysis)
- Bibliography
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