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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| Format: | Article |
| Language: | English |
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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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| author | Tarek A. Hammad Sasan Sabrdaran Hesham Aboshady Raquel Rogers Jean-Marie Heim Kim Bullano Tatiana Ishida |
| author_facet | Tarek A. Hammad Sasan Sabrdaran Hesham Aboshady Raquel Rogers Jean-Marie Heim Kim Bullano Tatiana Ishida |
| author_sort | Tarek A. Hammad |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-57955dc483eb4a06abacb4afe02e8fff |
| institution | Kabale University |
| issn | 2042-0994 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Drug Safety |
| spelling | doaj-art-57955dc483eb4a06abacb4afe02e8fff2025-08-20T04:02:41ZengSAGE PublishingTherapeutic Advances in Drug Safety2042-09942025-08-011610.1177/20420986251363378Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readinessTarek A. HammadSasan SabrdaranHesham AboshadyRaquel RogersJean-Marie HeimKim BullanoTatiana IshidaBackground: 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.https://doi.org/10.1177/20420986251363378 |
| spellingShingle | Tarek A. Hammad Sasan Sabrdaran Hesham Aboshady Raquel Rogers Jean-Marie Heim Kim Bullano Tatiana Ishida Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness Therapeutic Advances in Drug Safety |
| title | Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness |
| title_full | Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness |
| title_fullStr | Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness |
| title_full_unstemmed | Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness |
| title_short | Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness |
| title_sort | reflections operational lessons and practical insights from a pharmacovigilance inspection a case example of organizational strategies for medical safety readiness |
| url | https://doi.org/10.1177/20420986251363378 |
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