LOCAL AND REGIONAL
Our literature specialist team has 17 years experience in global pharma, with a focus on literature. Working with the customer, we can develop the search strategy and undertake sensitivity testing to ensure that search criteria are robust and appropriate for the purpose of the literature search. We can run the literature search and review the results, either for specific purposes (e.g. for aggregate reports, signal evaluation or other assessment of benefit-risk) or for ongoing screening of worldwide literature as required by local and regional requirements (e.g. for the EU, at least weekly literature screening must be performed for all products with, or under application for, a Marketing Authorisation).
As part of the ongoing screening, we can identify any ICSRs valid for entry into the safety database, including performing case processing and reporting of ICSRs and identify any potential emerging safety concerns or safety signals.
QVigilance can also monitor and review the Eudravigilance Medical Literature Monitoring, maintained by the European Medicines Agency (EMA), for ICSRs identified in the literature if the customer’s product(s) is included in the list of active substances.
Where we are providing local pharmacovigilance representatives who are required to perform the review of specific local non-indexed scientific and medical journals, our local representatives can fulfil this requirement for the identification and processing of ICSRs and other relevant safety information.