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Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities
David John Lewis1,2, John Fraser McCallum3
1Novartis Global Drug Development, Novartis Pharma GmbH, Oeflinger Strasse 44, D-79664, Wehr, Germany. david-1.lewis@novartis.com.
Intelligent automation offers significant opportunities to enhance pharmacovigilance (PV) systems. Automating the processing of individual case safety reports (ICSRs) improves data quality and expedites risk assessment for medicines.
Area of Science:
- Pharmacovigilance and Pharmaceutical Industry
- Information Technology in Healthcare
- Regulatory Science
Background:
- Advanced information technology (IT) presents both challenges and opportunities for pharmacovigilance (PV) systems.
- Automation can significantly improve standardization and data quality within PV processes.
- The rapid evolution of technology necessitates continuous evaluation of PV systems' fitness for purpose.
Purpose of the Study:
- To explore the challenges and opportunities of deploying advanced IT and automation in pharmacovigilance.
- To present a use case focusing on the automation of individual case safety report (ICSR) processing.
- To propose approaches for validating automated PV systems and discuss future research directions.
Main Methods:
- A use case analysis of automating the workflow for processing individual case safety reports (ICSRs).
- Development of themes addressing challenges, solutions, and research potential in PV automation.
- Presentation of definitions, critical appraisals, and validation approaches for automated PV systems.
Main Results:
- Intelligent automation can enhance PV systems, improving efficiency and data quality.
- Automating ICSR processing streamlines the workflow for effective safety data management.
- Validation strategies for automated PV systems are crucial for ensuring continued fitness for purpose.
Conclusions:
- Advanced IT and intelligent automation hold substantial potential to improve pharmacovigilance operations.
- Streamlined and automated processes for ICSRs lead to higher quality safety data, faster.
- Collaboration between system owners and regulators is essential for evaluating and implementing new technologies in PV.
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