Trend Analysis of Pharmacovigilance Audits
ON DEMAND
Pharmacovigilance compliance remains a critical priority in the life sciences sector, with global audits playing a key role in identifying risks and driving continuous improvement.
In this session, we will explore how these audits have shaped our understanding of global pharmacovigilance compliance. Our experts will present the results of a comprehensive analysis of more than 3,500 findings, highlighting the most frequent and critical issues across different auditee types.
What will I learn?
Overview of which entities may be subject to pharmacovigilance audits
What are the main observations found during Pharmacovigilance audits and their criticality
What are the most frequent pharmacovigilance findings, categorized by type of auditeeAbstract
Between 2022 and 2024, PQE conducted pharmacovigilance audits in over 75 countries, covering a wide range of stakeholders — including Marketing Authorization Holders (MAHs), service providers, affiliates, and distributors. Recently, PQE performed a global analysis of more than 3,500 findings collected during these audits, identifying key compliance trends and risk areas across the pharmacovigilance landscape.
In this TeqTalk, our experts will present the most frequent and critical findings, grouped by auditee type and severity, and will compare them with Health Authority inspection outcomes. Special focus will be given to recurring gaps in Quality Systems, Case Management, Pharmacovigilance Agreements, and Signal Management, as well as to the evolving nature of audit execution — from on-site to remote.
The session will offer actionable recommendations for improving oversight, strengthening training, and using audit data as a predictive tool for inspection readiness. Whether your organization is regularly audited or preparing for its first pharmacovigilance inspection, this session provides valuable insights to help you reduce risk and promote continuous improvement.
Speakers
Martina Spano
Pharmacovigilance & Quality Assurance Consultant@ PQE Group
Eleonora Conti
Pharmacovigilance QA Consultant @ PQE Group
Moderator
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