Periodic safety update reports (PSUR) are required for all products that have marketing authorisation in the EU.
PSUR in pharmacovigilance represents a fundamental document and basic requirement for majority of regulative proceedings.
A PSUR in pharmacovigilance provides an overview of safety and efficacy (GVP Module VII) over a defined interval: they require careful preparation according to a standard format in order to comply with the regulations and must meet tight deadlines for submission. Periodic safety update reports (PSUR) can also be submitted to the US FDA following a waiver from the need to submit US-style reports, alternatively we can write the US periodic adverse drug experience report (PADER).
PSURs are considered important pharmacovigilance documents by the authorities and they are subject to intense scrutiny at the time of inspection in the EU. A PSUR in pharmacovigilance that fails to examine and critically review the safety of the product often lead to punitive demands from regulators for additional time- and resource-intensive cumulative analyses.
The regulations PSUR Pharmacovigilance are complex, and effective timetabling for multiple products can be difficult and lead to costly duplication of effort.
Development Safety Update Reports (DSUR) for clinical trials are required for studies with centers in any EU country: again, there is a standard requirement for content and for time of submission.
PrimeVigilance consultants and staff have years of experience of planning and writing periodic safety update reports, PADERs and DSURs in a cost-effective way. Whether it is a single simple DSUR or PADER or complex PSURs, we can meet the need.