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: | Tarek A. Hammad, Sasan Sabrdaran, Hesham Aboshady, Raquel Rogers, Jean-Marie Heim, Kim Bullano, Tatiana Ishida |
|---|---|
| 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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