European Medicines Agency [to 16 January 2016]
http://www.ema.europa.eu/

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15/01/2016
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2016
Measuring the impact of pharmacovigilance activities – PRAC adopts new strategy
The Pharmacovigilance Risk Assessment Committee (PRAC), at its January meeting, adopted a ‘Strategy on measuring the impact of pharmacovigilance activities’. The new 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)…

Measuring the impact of such activities is crucial in order to know whether the measures taken to minimise the risks of a medicine have been effective. Measuring the impact of pharmacovigilance activities also allows regulators to determine which activities are most successful and so helps to promote best practice and improve pharmacovigilance.

The new strategy adopted by the PRAC builds on existing activities in the Member States and the Agency and relies on a collaborative approach with stakeholders. The strategy will focus on four areas: measuring the effectiveness of risk-minimisation measures on specific products; measuring the effect of specific pharmacovigilance processes (e.g. spontaneous reporting of suspected adverse reactions, signal management); investigating how to ensure engagement of key stakeholders (e.g. patients, healthcare professionals); and further improving methodologies to determine the effect of pharmacovigilance activities on public health…

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12/01/2016
Human medicines: highlights of 2015
93 medicines recommended for approval – 39 new active substances
The European Medicines Agency (EMA) has released an overview of its 2015 key recommendations in relation to the marketing authorisations of new medicines and the safety monitoring of authorised medicines…