For products under development in interventional clinical trials, the aggregate report is the Development Safety Update Report (DSUR; ICH-E2F). For products with a marketing authorisation, the Periodic Benefit-Risk Evaluation Report, also commonly referred to as the Periodic Safety Update Report (PSUR), is used. These reports cover drug products, vaccines and combination therapies including drug-device products. While the DSUR is an annual report, the frequency of submission of the PSUR is usually dependent on the receiving NCA, time since authorisation, other products on the market with the same active ingredient, use in vulnerable populations and other known or potential risks with use of the product.
Our PV team are highly experienced in the delivery of aggregate reports, such as Development Safety Update Reports (DSURs), IND Safety Reports, Periodic
Safety Update Reports / Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs), and Periodic Adverse Drug Experience Reports (PADERs).
QVigilance can work in conjunction with the customer and can help support the document preparation and submission of aggregate reports by providing the following services: