EMA 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 organised by the European Medicines Agency (EMA) 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 the workshop’s recommendations, the Pharmacovigilance Risk Assessment Committee (PRAC) is revising its strategy to evaluate EU pharmacovigilance activities in a collaborative approach based on clearly defined process indicators and measures of patient health outcomes.

The objective of this information day is to take stock of the implementation of the strategy, to discuss enablers and barriers to impact and to foster collaboration and sharing of information amongst stakeholders.

• Framework for impact evaluation
• Systematic collection of impact relevant data
• Methodologies for measuring health impacts of pharmacovigilance activities
• Collaboration with novel information technology providers
• Active engagement and capacity building of patient communities and healthcare professional bodies to support impact research
• Implementing a process to identify intended (and unintended) public health outcomes of regulatory decisions

Stakeholders of pharmacovigilance including pharmaceutical industry, regulators, patients and consumers and their organisations, healthcare professionals and their organisations; academia.