Workshop: measuring the impact of pharmacovigilance activities

News 28/11/2016

The event will be web-streamed on 5-6 December

The European Medicines Agency (EMA) is organising a workshop to discuss methods to measure the impact of pharmacovigilance activities on patient safety. The event will be web-streamed from the EMA premises in London, from 13:00 UK time on 5 December to 17:00 UK time on 6 December 2016. You can follow the live broadcast by clicking on the 'multimedia' tab on the event page.

In January 2016, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) adopted a ' PDF iconStrategy on measuring the impact of pharmacovigilance activities' . This strategy details how to gather data and knowledge on the concrete effect of measures and processes meant to ensure the safe use of medicines for patients in the European Union (EU). The aim of this workshop is to facilitate the implementation of this strategy by recommending methodologies to measure the impact of pharmacovigilance activities and fostering the conduct of collaborative impact research with the scientific community.

A range of activities carried out in Europe ensure medicines are used as safely as possible. These include proactive planning of risk-minimisation measures before a medicine is authorised, the collection and analysis of suspected adverse drug reaction (ADR) reports, the detection and management of potential new safety signals for medicines, as well as the planning of post-authorisation studies to generate data on the use of medicines in the real world. It also includes measures taken for specific products after an EU safety review.

Measuring the impact of such activities is crucial in order to know whether the actions taken to minimise the risks of a medicine have been effective. It also allows regulators and stakeholders to determine which activities are most successful and to identify enablers for and barriers to such activities.

This workshop will bring together the expertise from international partners and stakeholders who participate in pharmacovigilance activities: regulatory and public health bodies, healthcare-professional and patient/consumer organisations, academia, learned societies and the pharmaceutical industry. It is expected to provide an overview of existing methods applied by various stakeholders to measure how effectively pharmacovigilance activities have been implemented in healthcare systems and how regulatory actions have changed the use of medicines in clinical practice for the benefit of patients.

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