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 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.
- Enhanced quality and speed through automation
- Greater consistency within a particular sponsor company’s case processing and reporting while limiting errors commonly associated with manual data processing
- Potential reallocation of resources to address more value-adding opportunities
- Catalyst for third party innovation in intelligent automation
The Initiative assets below are currently targeted for completion in Q3-Q4 2019:
- Utilizing Advanced Technologies to Augment Pharmacovigilance (PV) Systems: This whitepaper would help facilitate understanding of intelligent automation technology related terms in the PV context and present overall challenges and opportunities for PV
- Individual Case Safety Report Process Heat Map: The online tool and whitepaper will provide understanding of where opportunities for intelligent automation are in the ICSR process, and the level and type of benefits that could be achieved
- Guidance for Validation of Automated Pharmacovigilance Systems: The whitepaper will provide guidance to the industry on validation strategies being utilized and to facilitate dialogue with Health Authorities on this topic
Value of Safety Information Data Sources
The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for a single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.
Interpretation of Guidances & Regulations
The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.
Advancing Safety Analytics
This initiative aims to develop best practices and guidance around the application of interrogative methods towards various safety data sources.