EMA publish Pharmacovigilance Risk Assessment Committee (PRAC) Plan for 2024

On the 26th January 2024, the Pharmacovigilance Risk Assessment Committee (PRAC)  adopted their work plan for 2024.

The PRAC plan ensures their focus and delivery of key parameters and makes for an interesting read. Primarily they will be looking at the development of special populations and product guidance aimed at strengthening pharmacovigilance activities performed by industry and regulators. There will be revisions to GVP modules.

Other workstreams include optimising management and utility of reported adverse reactions, measuring the impact of pharmacovigilance activities and their continued engagement with stakeholders and PRAC process improvements.

Anyone connected with pharmacovigilance should take a moment to read through as it gives insight to changes which may be coming in the near future.

read the PRAC Plan

If you’ve any questions or require any support in pharmacovigilance we’d be more than happy to help. Please contact us at consultancy@jensongroup.com

James Hall