Overview Of Safety Over A Defined Interval
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If your company has a marketing authorisation in the EU, you may be required to prepare detailed periodic safety update reports, or other safety documents for your products.
These safety documents, e.g., PSURs are considered to be crucial Pharmacovigilance documents by the authorities. They must be carefully prepared in accordance to a standardised format for them to meet tight submission deadlines whilst also complying with the regulations as they are subject to intense scrutiny at the time of inspection.
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