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The Essentials of Pharmacovigilance

Posted on April 19th, 2016 by in Pharmacovigilance


Elsevier is attending the World Drug Safety Congress in Chicago this week—an important part of the pharmaceutical industry calendar that brings together experts involved drug safety to discuss new topics, challenges and technologies in this key area of pharmaceutical R&D.

Our focus is on the role that information providers play in drug safety. Joyce de Langen, Elsevier Senior Solution Manager Pharmacovigilance, is delivering a talk on the role of scientific literature in pharmacovigilance on Wednesday. The Elsevier team will be at Booth 11 for the entire event, prepared to suggest solutions and answer questions on how to ensure compliance with regulatory guidelines, while improving the efficiency of the literature screening process.

Why is pharmacovigilance so important? Defined as the science of monitoring, evaluating and improving the safety of drugs, at its simplest level, it is a post-market activity connected with reporting to regulatory authorities. However, its impact goes far beyond that.

Insights into adverse events inform decisions in early discovery, patient care and more. Truly efficient pharmacovigilance—meaning both the identification of all relevant drug safety information and the detailed assessment of adverse events—helps to reduce R&D costs and improve productivity. More importantly, the knowledge gained also has the potential to improve existing treatments and thus improve patient quality of life.

Efficient pharmacovigilance requires the means to find and assess the information quickly. Given the sheer volume of adverse events that can be found and reported in a year, this task requires multiple approaches, such as:

  • Reliable text-mining tools that can find and extract essential information, even from full-text literature
  • Comprehensive literature resources that include biomedical journal articles and conference proceedings
  • Up-to-date regulatory information
  • A workflow management solution that automates the process of monitoring and triaging articles
  • The support of professional services teams that can integrate resources into streamlined systems

Fortunately, these resources and services exist and are available to drug safety researchers. We are living in an age of ever-improving access to such essential drug development information. The promise of further improvements in patient quality of life is real.

Want to know more about Elsevier R&D Solutions and our support for pharmacovigilance? This short video explains how we support this critical task.

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