Why Are Correct Screening Procedures So Important?

According to Module VI of the EU Guideline of Good Pharmacovigilance Practices (GVP) , the regulators expect every marketing authorisation holder to incorporate literature screening procedures as an integral part of your daily drug safety operations.

Almond Pharma operate a comprehensive Worldwide Pharmacovigilance Literature Screening Service as part of our drug safety services. With the use of databases like Embase and Medline.

At least once a week, we will systemically monitor the “active substances”, assessing the relevant database by screening abstracts for the identification of:

  • Potential new and significant safety findings
  • symptomatic overdose, abuse or misuse
  •  Identification of potential ICSRs
  • Pregnancy outcomes (including termination) with no adverse outcomes;
  • Use in paediatric populations
  • Lack of efficacy
  • Medication error where no adverse events occurred
  • Sending the results of this task to the suitable departments in your company
  • Analysing and describing any “new and significant safety findings”

Why Choose Almond Pharma for your Pharmacovigilance Literature Screening Service?

The need to proactively screen the published scientific and medical literature as part of a Pharmacovigilance system can potentially lead to difficulties during  regulatory authority inspections, as insufficient searches are a common finding. We appreciate that literature screening can be resource intensive and time-consuming and evaluating these cases can be  complex and difficult.

The benefit of contracting Almond Pharma to do your Literature Screening for you is that our team have years of experience in this particular area and can comprehensively manage your literature screening requirements in the most cost-effective way possible.

For purposes of signal evaluation, we can also carry out identifying safety concerns for inclusion in PSURs or literature searches.

REFERENCES:

  • 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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