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:
- Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities: This published paper helps facilitate understanding of intelligent automation technology-related terms in the PV context and presents overall challenges and opportunities for PV
- Automation Opportunities in Pharmacovigilance: An Industry Survey: This paper intends to summarize the ICSR process details, identify and prioritize automation opportunities, address the need for a systematic review framework of the ICSR process, and provides important foundational information for those new to the pharmacovigilance space.
- Interactive ICSR and Automation Technologies Tool (IATT): The online tool and published paper will provide an understanding of where opportunities for intelligent automation are in the ICSR process and the level and type of benefits that could be achieved
- 2020 Technology Matrix: 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
- Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices: 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.