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The Role of Scientific Literature in Pharmacovigilance: Challenges and Solutions

Posted on May 6th, 2016 by in Pharmacovigilance


After our recent webinar, Elsevier received several questions from attendees. During the next few weeks, we will discuss some of the questions in more detail. 

Adverse drug reactions are an important risk for patient safety and have significant impact on costs of health systems. Because of this major impact on patient safety and public health, regulatory authorities worldwide have implemented new pharmacovigilance legislation in the recent years.

Underreporting by health care professionals increases need for other sources of adverse drug reactions

Historically, pharmacovigilance activities mainly rely on signal detection activities performed on data from spontaneous reporting systems. However, due to underreporting by health care professionals, new legislation focus increasingly on the relevance of other sources of safety information, such as scientific literature, for signal detection and monitoring the benefit-risk profile of medicinal products.

Literature is an important source of adverse drug reactions

Literature is the one of the largest sources of adverse drug reactions. Screening scientific and medical literature to identify adverse drug reactions is a regulatory obligation for pharmaceutical companies. However, pharmaceutical companies are facing a number of challenges with regard to literature management for pharmacovigilance. The main challenges are:

  • Differences between regulatory requirements
  • Building the perfect search strategy
  • Handling a big amount of unstructured data
  • Local Language Monitoring
  • Integrating results from EMA MLM Service
  • Quality/completeness of the information related to the adverse drug reaction

Challenges and solutions when screening literature for adverse drug reactions

As discussed in Elsevier’s webinar about ‘The role of scientific Literature in pharmacovigilance – challenges and solutions’, software solutions can support pharmaceutical companies with their literature management activities. Let us know the challenges you are facing when monitoring scientific literature for pharmacovigilance purposes and join our discussion at the Pharma R&D Today.


This weeks Question: 

Do the regulatory authorities specify when to start monitoring literature for pharmacovigilance purposes?

According to legislation Marketing Authorisation Holders are expected to start monitoring literature with submission of a marketing authorization application and literature monitoring should continue while authorization is active. 

View the recorded webinar: The Role of Scientific Literature in Pharmacovigilance: Challenges and Solutions

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