European Medicines Agency information day on measuring the impact of pharmacovigilance activities

Measuring the impact of pharmacovigilance is essential to allow regulators and pharmaceutical industry to ensure key pharmacovigilance activities are effective and efficient and to support regulatory decisions. Effective risk minimisation balancing benefits and risks of medicines are important tools for patient empowerment and to achieve best public health outcomes. A workshop in 2016 highlighted the need for a sustainable framework, robust scientific methodologies, timely generation of decision-relevant data and clear roles and responsibilities as key pillars of impact research. Based on these recommendations, PRAC is revising its strategy to evaluate EU pharmacovigilance activities in a collaborative approach with clearly defined process indicators and measures of patient health outcomes. At this event stakeholders discuss methodologies for impact research, enablers and barriers to impact, and foster collaboration and sharing of impact relevant information.