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The medical literature is a significant source of information for the monitoring of the safety profile and assessment of the benefit-risk ratio of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. According to GVP Modules VI and IX, it is essential to maintain awareness of relevant publications through a systematic literature review of widely used reference databases (e.g., Medline, Embase) no less frequently than once a week. In addition, there is a need to monitor scientific and medical publications in local journals in countries where the medicinal product has a marketing authorisation, and to bring them to the attention of the company safety department as appropriate. Reports of suspected adverse reactions from the medical literature should be reviewed and assessed to identify and record ICSRs (GVP Module VI).
- LITERO offers you service for regular weekly searches of the published medical literature in reference databases suitable for your medicinal product. This can range from access to a particular database interface (access to a technology) to full literature searching or review and ICSRs submission (using the professional pharmacovigilance services of your organisation).