PSUR

Periodic Safety Update Reports (PSURs)

PSURs are periodic reports in which the benefit-risk profile of a medicinal product is evaluated.

We offer you the creation of individual PSURs as well as cross-company, pooled PSURs in the form of PSUR templates according to your company-specific needs. The content of the reports is created in accordance with GVP Module VII and provided in an editable format.

• Individual PSUR

   

  An individual PSUR is prepared in accordance with the Good Pharmacovigilance Practices (GVP) Guideline and is therefore “ready for delivery”. It includes:

  • • Published studies
    • Company-specific information (spontaneous registrations, including line listings, summary tabulations and narratives, sales figures, and registration data)
    • Texts and analyses (including risk-benefit analysis)

• Pooled PSUR

   

  This is an active-ingredient-related PSUR template – this includes, among other things:

  • • Extensive text modules
    • Summary tabulations on literature cases
    • Published studies
    • Bibliography

Would you like to know more?

We are pleased that you are interested in our PSUR services. We would be happy to present our service tools in detail – just contact us.