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Medical literature is a significant source of information for monitoring the evolving safety profile and risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
Local Literature Monitoring plays a key part in that safety data collection because many local sources are not captured and indexed in large commonly used international databases, leaving potential important safety information unchecked.
In many countries and regions, Local Literature Monitoring is a requirement that is embedded in legislation, as per EU GVP Module VI, and it is required from the moment of Marketing Authorization. The safety information obtained from Local Literature Monitoring is therefore an indispensable component of an effective and compliant pharmacovigilance system.
Search strategy development.
The systematic review of all local literature sources agreed in the search strategy.
The identification and reporting of Individual Case Safety Reports (ICSRs).
The identification of any other relevant safety information.
The procurement and translation of full-text articles when necessary.
A quality control process throughout the screening process.
The consolidation of local literature outputs across all monitored countries into a single comprehensive report
Monthly compliance monitoring and reconciliation.
iVigee has extensive experience with Local Literature Monitoring and our dedicated team understands the importance of monitoring non-indexed scientific and medical local literature sources for safety information.
Through our extensive local network, and our world leading regulatory intelligence platform iViReg, we stay fully up to date with local requirements and changes around the world and adapt our monitoring strategies accordingly to ensure we provide a comprehensive search of all relevant local safety information.
Our process starts with defining a local literature search strategy based on a combination of your product portfolio and it’s marketed locations, iVigee’s knowledge of local literature in those locations, and the current regulatory requirements of those locations.
We also take into consideration the recommendations of experienced native language speakers on which journals should be monitored, along with specific keywords in both English and the language involved.
We typically perform Local Literature Monitoring on a monthly basis, although of course the publication cycles of different journals can vary from monthly, quarterly, or even annually.
Our nominated native speaker will perform the literature monitoring and usually we also nominate a deputy for both business continuity and quality review.
We also assign a dedicated local network coordinator for every client who coordinates the entire monitoring process and outputs for all the countries involved and serves as the central client contact for all queries.
iVigee aims to provide you with comprehensive, accurate, and relevant local safety information that meets regulatory requirements around the world, ensuring your pharmacovigilance system is compliant, and making us an invaluable partner in your pharmacovigilance strategy.
