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Periodic Safety Update Reports (PSURs)

The Pooling Project Pharmacovigilance offers two options within its PSUR-writing service: customized PSURs (including all company- and product-specific data) and pooled PSURs, which are templates containing only the data from the literature research for a specific substance.

The pooled PSURs can be used by any firm with that particular active substance to generate their own specific PSUR, but at a much lower cost, as the costs are divided among the participating firms. The BPI Service PSUR templates include the literature entries, narratives, line listings and summary tabulations generated from literature research results for a specific harmonized reporting period. For substances that can be administered both locally and systemically, two PSUR templates are generated to provide for this differentiation, where it is appropriate.

For the remaining parts of the PSUR, the template includes text modules that can easily be completed with company-specific data. This strategy allows the firm to complete the PSUR in significantly less time and at a significantly lower cost.

To give an idea of the structure of the pooled PSUR template, please click on the menu item Demo-Template, where you will see images of some parts of the template.