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 speed through automation
- Greater consistency within a particular sponsor company’s case processing and reporting while limiting errors commonly associated with manual data processing
- More efficient allocation of resources to address more immediate priorities
- Catalyst for third party innovation in intelligent automation
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 pharmacovigilance requirements that seem ambiguous.
Advancing Safety Analytics
This initiative aims to develop best practices and guidance around the application of interrogative methods towards various safety data sources.