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calendary April 2, 2024

Artificial intelligence in pharmacovigilance

The US Food and Drug Administration (FDA) receives approximately 2 million reports of adverse drug reactions each year, each of which requires review. In 2022, to facilitate information processing, the Department of Surveillance and Epidemiology launched the Information Visualization Platform (InfoViP), created on the basis of artificial intelligence.

Upon receiving information about adverse drug reactions, the FDA must decide whether to initiate a safety signal for approved drugs, that is, a possible cause-and-effect relationship between the adverse reaction and the drug. Processing the received information involves a large amount of labor, as well as human interactions, but this process may well be delegated to artificial intelligence.

The Visualization Platform (InfoViP) can, for example, process language information to extract various data from incoming drug adverse event cases, as well as classify adverse event reports according to the quality of the information.

In Russia, back in 2020, automatization of the pharmacovigilance system was announced. According to the publication of the Pharmvestnik portal dated October 15, 2020, the regulator planned to process 100% of reports of adverse reactions when using drugs with the help of artificial intelligence technologies by 2023.

In 2022, Roszdravnadzor launched a new functionality of the Pharmaconadzor subsystem. As part of this functionality, it has become possible to automatically transmit messages about adverse reactions from the database of marketing authorization holders directly to the Pharmacovigilance 2.0 database (“Gateway”).

References:
  1. https://www.raps.org/News-and-Articles/News-Articles/2024/2/Official-FDA-modernizing-pharmacovigilance-oversig
  2. https://pharmvestnik.ru/content/news/II-budet-obrabatyvat-soobsheniya-o-pobochnyh-effektah-dlya-FDA.html
  3. https://pharmvestnik.ru/content/news/Roszdravnadzor-vnedrit-iskusstvennyi-intellekt-v-farmakonadzor.html
  4. https://pharmprom.ru/roszdravnadzor-zapustil-novyj-funkcional-podsistemy-farmakonadzor/

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