Global and Local Literature Screening

Published medical and scientific literature is a valuable source of information regarding medicinal products and medical devices. And Marketing Authorisation Holders (MAHs)/Licence Holders are required to monitor the literature for suspected Adverse Drug Reactions (ADRs) and other important safety information such as class effects, off-label use, misuse and potential drug interactions. Within the European Union, it is required that upon submission of a MA application, the MAH will conduct at least weekly searches of the global literature to identify any emerging safety information.


Literature Screening

Local (non-indexed) literature searches may also be required to review journals relevant to the therapeutic area or patient population. Literature searches should be constructed in such a way to identify both Individual Case Safety Reports (ICSRs) of Adverse Reactions and relevant safety information (e.g. class effects) for consideration in periodic reports.

The European Medicines Agency (EMA) also screen global literature for ADRs associated with certain EU authorised products via the Medical Literature Monitoring (MLM) service. The MAH should monitor and download ICSRs for their products where these are included in the MLM list of products.

QVigilance’s Pharmacovigilance Specialists are experienced with performing literature searches.

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.


Local and Regional Representatives

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.

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