Extending the Reach for Pharmacovigilance Professionals

  • October 18, 2018
  • Andrew

There are multiple regulatory agency cooperative initiatives involving digitization and standardization like the WHO Programme for International Drug Monitoring VigiBase, FDA  Sentinel Initiative (2016 system launch),  and European Medicines Agency EudraVigilance (2017 system launch), which are national and multinational examples of agencies seeking to transform and extend pharmacovigilance capabilities.


Vigibase is the world largest individual case report database with records from over 110 member countries representing over 90% of the world’s population.


Sentinel is a U.S. partnership effort between public, academic, and private entities to develop a system to obtain information from large amounts of existing electronic healthcare records to assess the safety of approved medical products.


Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market and complements the Agency’s existing Medwatch and Adverse Event Reporting System.


Case studies have already demonstrated earlier detection of adverse event signals and these efforts are sure to continue to grow.  See  Sentinel Final Assessment Report (2017) and 2017 Sentinel Case Studies Public Workshop.


These and other programs are extending pharmacovigilance practices into new domains.  It is creating connections and more dialogue between researchers, manufacturers, medical professionals, and the patients they serve.


This is certain to enhance patient safety and our medical knowledge.

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