Module 1 2021

28/06/2021

PRAC: Pharmacovigilance Risk Assessment Committee EMA’s Committee responsible for assessing and monitoring the safety of human medicines.

The Organisation for Professionals in Regulatory Affairs

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Risk Management Plan: Overall Content

Risk Management is a continuous process throughout the lifecycle of a medicinal product.  Safety specification: - What we know, and what we do not know about the product’s safety profile (important identified and potential risks, missing information)  Pharmacovigilance plan: - Actions to increase our knowledge about the clinically relevant risks and to identify new Adverse Drug Reactions  Risk minimization measures: - Actions to minimize the risks of the product, including evaluation of the effectiveness of these actions

Risk identification

Risk characterization and monitoring

Actions effective?

Risk minimisation

The Organisation for Professionals in Regulatory Affairs

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