Module 1 2021

28/06/2021

Post-Approval Safety

The Organisation for Professionals in Regulatory Affairs

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Post-Approval Safety

The past: A reactive process. • A decent process to ensure that side effects were reported, analyzed and put into the label when needed, was sufficient • Benefit / risk balance Today: a pro-active, strategic approach • Approvals based on limited data lead to uncertainties about safety. • (benefit + uncertainties) / (risk + uncertainties)

The reaction of the regulators:  Formalization within the Pharmacovigilance regulation, including the establishment of the PRAC, the RMP and other measures to control the product safety and its uncertainties.

The Organisation for Professionals in Regulatory Affairs

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