Pharmacovigilance, or the practice of monitoring the effects of medicines after they have been released for commercial use, was expanded in 2002 by the World Health Organization (WHO) to include signal detection as a way of improving patient care and improving the overall health and safety of the general public. Today, pharmacovigilance activities should also contribute to the risk-benefit profile of the drug of interest.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
It is also interesting to note that the WHO sees pharmacovigilance as having a role in helping the general public better understand the safety monitoring of individual drugs. In essence, this implies that the safety profiles of drugs should not reside solely with marketing authorization holders and regulatory authorities, but should instead be shared with the broader community.
Check back for the next post in this series on drug safety: post-marketing surveillance. While you wait, enjoy this guide on drug safety.