Risk-Based Auditing in Pharmacovigilance: What Changes with EU Regulation 2025/1466?

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The Pharmacovigilance Podcast

Julia Appelskog

17 episodes

6 days ago

The Pharmacovigilance Podcast is your gateway to understanding how technology, regulation, and innovation converge to safeguard patient safety. Our discussions span legislation updates and AI's practical application in pharmacovigilance workflows. Stay ahead of the curve with The Pharmacovigilance Podcast – where safety meets innovation.

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Health & Fitness

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The Pharmacovigilance Podcast is your gateway to understanding how technology, regulation, and innovation converge to safeguard patient safety. Our discussions span legislation updates and AI's practical application in pharmacovigilance workflows. Stay ahead of the curve with The Pharmacovigilance Podcast – where safety meets innovation.

Show more...

Health & Fitness

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Risk-Based Auditing in Pharmacovigilance: What Changes with EU Regulation 2025/1466?

The Pharmacovigilance Podcast

16 minutes 36 seconds

2 weeks ago

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 Natiyal, 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-auditingConnect 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