Updating Safety Information: Writing PSURs and Annual Safety Reports

Periodic safety update reports (PSURs) and Annual Safety Reports (ASRs) are required by the regulatory authorities on a regular basis to update the worldwide safety experience with marketed drugs. Medical writers are increasingly being asked to compile such reports on behalf of pharmacovigilance departments. The aim of this workshop is to provide a clear explanation as to what these reports are, when they need to be produced, what data should be included and how it should be presented.


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