GVP Module VI makes it clear that regulators expect consistent screening to be an integral part of your day-to-day drug safety operations. For each marketing authorisation you hold, you are expected to:
PrimeVigilance operates a comprehensive Worldwide Pharmacovigilance Literature Screening Service as part of the suite of drug safety services offered by the company. Features include:
Your service may be extended to full or part service including:
The requirement to proactively screen the published medical and scientific literature as part of a pharmacovigilance system can lead to difficulties: the screening can be time-consuming and resource intensive; inadequate searches are a common finding during regulatory authority inspections; and the identified cases can be complex and difficult to evaluate and to enter onto the safety database.
One benefit of contracting PrimeVigilance to carry out your Literature Screening for you is that we have been offering it as part of our range of drug safety services for a number of years. Our staff have extensive experience in this arena and can comprehensively manage your literature screening requirements in a cost-effective manner. Involving medical review of cases rather than adopting a mechanistic approach can also help to identify important signals in the literature. We can also utilise our existing international network to establish screening of the local, non-indexed medical and scientific literature.
We can also carry out literature searches for purposes of signal evaluation or for identifying safety concerns for inclusion in PSURs.
For more information contact PrimeVigilance today
Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products
Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report
21CFR314.80 Postmarketing reporting of adverse drug experiences
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