A comprehensive checklist for auditing pharmaceutical pharmacovigilance systems to ensure compliance with global regulations, maintain effective drug safety monitoring, and protect patient safety throughout the product lifecycle.
Pharmaceutical Pharmacovigilance System Audit Checklist
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About This Checklist
The Pharmaceutical Pharmacovigilance System Audit Checklist is an essential tool for ensuring the effectiveness, compliance, and reliability of drug safety monitoring processes. This comprehensive checklist addresses key aspects of pharmacovigilance, from adverse event reporting to signal detection and risk management, helping to maintain patient safety and regulatory compliance. By implementing this checklist, pharmaceutical companies can enhance their pharmacovigilance practices, meet global regulatory requirements, and demonstrate their commitment to ongoing drug safety monitoring throughout the product lifecycle.
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Ensures compliance with global pharmacovigilance regulations and guidelines
Improves the efficiency and effectiveness of adverse event reporting and processing
Enhances signal detection and evaluation processes
Supports timely and accurate safety communications to stakeholders
Facilitates continuous improvement of the pharmacovigilance system
