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Periodic reporting (PSURs/PBRERs)
Companies are required to prepare detailed periodic safety update reports on all their products that have marketing authorisation in the EU. The PSURs provide 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. PSURs 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. PSURs that fail 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 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 centres 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 PSURs, PADERs and DSURs in a cost-effective way. Whether it is a single simple DSUR or PADER or a complex PSURs, we can meet the need.