Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness
Background: Pharmacovigilance (PV) inspections are critical regulatory assessments that evaluate the robustness and compliance of a company’s drug safety system. Despite their significance, there is limited published guidance on how organizations—particularly Medical Safety functions—can prepare ope...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2025-08-01
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| Series: | Therapeutic Advances in Drug Safety |
| Online Access: | https://doi.org/10.1177/20420986251363378 |
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| Summary: | Background: Pharmacovigilance (PV) inspections are critical regulatory assessments that evaluate the robustness and compliance of a company’s drug safety system. Despite their significance, there is limited published guidance on how organizations—particularly Medical Safety functions—can prepare operationally for such inspections. Objectives: To share practical, experience-based insights and organizational strategies for inspection readiness, execution, and follow-up, based on a recent large-scale European Medicines Agency PV inspection. Design: Descriptive case-based manuscript outlining the stepwise activities undertaken before, during, and after a regulatory PV inspection, with a focus on Medical Safety coordination. Methods: An internally coordinated approach was implemented, including preparatory meetings, document request management, cross-functional mock inspections, role assignments, and communication planning. A structured system was established for Medical Safety responses involving on-site and remote collaboration among safety leaders. Results: The inspection was successfully completed. The coordinated system enabled timely, consistent, and quality-controlled responses. Visual tools, including timelines and workflows, supported operational efficiency and stakeholder alignment. Post-inspection debriefs further informed process improvements across Medical Safety functions. Conclusion: This manuscript provides a practical, case-based framework for PV teams to approach regulatory inspections with strategic foresight and cross-functional coordination. The experience shared can serve as a useful reference, particularly for Medical Safety professionals and organizations seeking to strengthen inspection readiness and compliance operations. |
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| ISSN: | 2042-0994 |