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