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Risk-Based Auditing in Pharmacovigilance: What Changes with EU Regulation 2025/1466?
In this episode, we discuss the new auditing requirements in pharmacovigilance and how risk-based auditing is transforming the way companies conduct their operations.
Our guest, Pankaj Nautiyal, is a pharmacovigilance expert with over 18 years of experience in global pharmacovigilance compliance and PV auditing. We discuss:
• What risk-based auditing really means
• How the new regulation affects MAHs and subcontractors
• What needs to change in audit plans, contracts, and quality systems
• Practical tips to stay compliant without over-auditing
Connect with Pankaj on LinkedIn: https://www.linkedin.com/in/pankaj-nautiyal-b5565912/
Read the regulation here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R1466
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By Julia AppelskogIn this episode, we discuss the new auditing requirements in pharmacovigilance and how risk-based auditing is transforming the way companies conduct their operations.
Our guest, Pankaj Nautiyal, is a pharmacovigilance expert with over 18 years of experience in global pharmacovigilance compliance and PV auditing. We discuss:
• What risk-based auditing really means
• How the new regulation affects MAHs and subcontractors
• What needs to change in audit plans, contracts, and quality systems
• Practical tips to stay compliant without over-auditing
Connect with Pankaj on LinkedIn: https://www.linkedin.com/in/pankaj-nautiyal-b5565912/
Read the regulation here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R1466