Sponsor Oversight Failures in Pharmacovigilance Audit Findings
Sponsor Oversight Failures in Pharmacovigilance Audit Findings Why Sponsor Oversight Failures in Pharmacovigilance Trigger Regulatory Findings Introduction: The Sponsor’s Role in Pharmacovigilance Oversight Sponsors bear ultimate responsibility for the safety of investigational products, regardless of whether pharmacovigilance activities are delegated to a Contract Research Organization (CRO). Oversight of Serious Adverse Events (SAEs), Suspected Unexpected Serious…
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