Module 12 Presentations

EU Pharmacoviligance legislation

It was observed that adverse drug reactions caused around 197,000 deaths per year in the EU. This caused the European Commission in 2005-2007 to review the European system of safety monitoring.

This resulted in the European pharmacovigilance legislation , which came into effect in July 2012

Aims:

✓ The collection of better data on medicines and their safety;

✓ Rapid and robust assessment of issues related to the safety of medicines;

✓ Effective regulatory action to deliver safe and effective use of medicines;

✓ Empowerment of patients through reporting and participation;

✓ Increased levels of transparency and better communication .

To safeguard the “Safety of the patient”, a lot of information is needed across the Medicinal Product Lifecycle and regulatory activities (more than just Pharmacovigilance data).

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12