Periodic Safety Update Reports (PSURs)
According to the company's specific requirements and needs, we offer both the compilation of complete PSURs, and the provision of cross-company pooled PSURs in the form of PSUR templates. All PSUR documents will be provided in an editable digital format.
- Flyer PSUR
Customized PSURs
Complete Volume 9A compliant PSURs. Customized PSURs include:
- all narratives for literature cases
- Line Listings for literature cases
- Summary Tabulations for literature cases
- published studies
- company-specific information (direct reports including Summary Tabulations, Line Listings and narratives, sales figures, authorization data)
- bibliography
"Pooled" PSURs
Active substance specific PSUR template. "Pooled" PSURs include:
- comprehensive suggested test modules
- all narratives for literature cases
- Line Listings for literature cases
- Summary Tabulations for literature cases
- published studies
- bibliography
Additional rebates will be granted when several firms buy the same PSUR template (harmonization).
For further information please visit www.psur.de.
You can find a collection of relevant regulative pharmacovigilance documents in our pharmacovigilance document library.