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:
- Signal Management – Intelligent Automation Opportunities for Signal Detection
- Artificial Intelligence (AI)-based Validation Case Study Themes
- Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
- Interactive ICSR and Automation Technologies Tool (IATT)
- Technology Matrix
- Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance
- Black Swan Events and Intelligent Automation for Routine Safety Surveillance
- Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices
- Automation Opportunities in Pharmacovigilance: An Industry Survey
- Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities
