Intelligent Automation Opportunities in Pharmacovigilance

The Intelligent Automation Opportunities in Pharmacovigilance Initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes.

Rationale

Given the wide variety of global regulatory requirements, managing the volume, variety and velocity of pharmacovigilance data presents a significant challenge. Operations that are repetitive in nature and of relatively low business value are ripe for automation to gain efficiencies and reduce costs.

The Intelligent Automation Opportunities in Pharmacovigilance Initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes. By conducting an impact assessment and working with global health authorities to verify risks/issues with their use, this initiative will provide guidance, as appropriate, on applications of new technology in Pharmacovigilance practice.

Benefits

  • Understanding technological foundations and their applicability to PV systems
  • Evaluating the opportunity for using intelligent automation in the ICSR process
  • Benchmarking intelligent automation technologies for specific ICSR process steps
  • Educating PV organizations regarding the implementation intelligent automation technologies

Available Solutions

The Initiative assets below are currently available:

The following asset is in development for 2020:

  • Guidance for Validation of Automated Pharmacovigilance Systems: This position paper will provide considerations to the industry on validation strategies being utilized and is intended to facilitate dialogue with Health Authorities on this topic

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