Local Literature review - ICSRs AND Articles of interest?
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For local literature review, everyone is familiar with the necessity and requirements for screening relevant local journals for ICSRs. However is there any requirement to actively screen relevant journals for 'Articles of Interest' for example for inclusion within PBRERs or PSURs?
yes, Anon .There are list of world wide databases and suggested keywords to search with in case of making literature search for PSUR . you can contact me on my email
email@example.com to provide you with the list.
RQA GPvP Committee
in addition to the response already provided, we would like to refer you to the EMA's GVP Module VII – Periodic safety update report (Rev 1), where VII.B.5.11. PSUR section “Literature” states why the search for the purposes of the PSUR (and that would also apply for Risk Management Plans) should be wider than only ICSRs.
VII.B.5.11. PSUR section “Literature”
Literature searches for PSURs should be wider than those for individual adverse reaction cases as they should also include studies reporting safety outcomes in groups of subjects and other products containing the same active substance.
We hope you find this useful.