PSURs are considered important pharmacovigilance documents by the authorities and they are subject to intense scrutiny at the time of inspection in the EU. 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). PSUR in pharmacovigilance represents a fundamental document and basic requirement for majority of regulative proceedings.Ī 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) are required for all products that have marketing authorisation in the EU.
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