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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.



A peer-reviewed article that reports on an analysis performed to provide a first-time quantification of the amount of ICSR (Individual Case Safety Report) replication taking place within the pharmacovigilance ecosystem.  The analysis utilizes aggregated ICSR transmission data from seven participating TransCelerate member companies, which accounts for 20% of the total ICSR case volume reported to the FDA.

Provides technology survey benchmarking data for the 2020-2021 period, regarding the types of technologies available in pharmacovigilance with an aggregated view of the level of implementation of each technology with each Individual Case Safety Report (ICSR) process step, comparing the aggregated implementation levels across time periods.

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. Here is a video discussing the paper in detail.

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. Here is a video discussing the paper in detail.

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.

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.

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