Module 6

03/10/2024

MSc Regulatory Affairs: Module 6

Pharmacovigilance and Risk Management

Amalia Alexe, Clin Pharm Policy & Liaison Lead, Global QPPV PRRC Office, Novartis Pharma GmbH Acknowledgement to Prof Dr David Lewis, University of Hertfordshire

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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Learning Outcomes

⚫ To have an understanding of the responsibilities and requirements of the Marketing Authorisation Holder to maintain the product licence with respect to protecting patient safety by: ● Establishing and maintaining an effective PV system ● Reporting adverse events on expedite and in aggregate ● Detecting, managing and responding to safety signals ● Ensuring that all licensed medicinal products have an established positive benefit risk assessment and that this is maintained over time

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