Module 5 Presentations

05/07/2024

Pharmacovigilance activities for clinical trials in the UK and EU

Dr Maria Beatrice Panico 18 July 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning objectives

• UK legislation from 1 st of January 2021 • Current legislation in the European Union (EU) • Reference Safety Information (RSI) • Suspected Unexpected Serious Adverse Reactions (SUSARs) • Development Safety Update Reports (DSURs) • Urgent Safety Measures (USMs) • Risk mitigation strategies

The Organisation for Professionals in Regulatory Affairs

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