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Intelligent Automation Opportunities in Pharmacovigilance Solutions

Intelligent Automation Opportunities in Pharmacovigilance Initiative is focused on identifying opportunities for utilizing different types of intelligent automation technologies to improve industry PV process quality, efficiency, and PV data insights, ultimately to improve PV work for patient safety.



This published paper is a follow-up to the ICSR Paper which combines data from 2019-2021​.  The paper describes major trends​, interprets and suggests why these trends exist​, includes an updated ICSR Heat Map​ and includes an update for case studies from the Foundation Paper Table 2.

This published paper discusses black swan events in the context of pharmacovigilance and the role of machine learning in helping to mitigate such events.  The paper explores effective approaches to managing risk of potential black swan events and outlines several strategies to address those risks of potential black swan events during data ingestion.

Facilitates understanding of intelligent automation technology-related terms in the PV context. Also, it includes a summary of current use cases.

Maps the Individual Case Safety Report (ICSR) process and evaluates opportunities for intelligent automation within that process in terms of perceived risk, the effort required and expected benefit.

Provides information regarding the types of technologies available in pharmacovigilance and maps the level of implementation of each technology to the Individual Case Safety Report (ICSR) process.

This position paper provides considerations to the industry on validation strategies that can be utilized for emerging AI-based automation technologies. It is intended to facilitate dialogue and collaboration with Health Authorities and industry on this topic. Here is a video discussing the paper in detail.

A tool to help companies better understand and utilize our solutions as they explore the use of intelligent automation for pharmacovigilance.