On 16 & 17 June in London, EFA board member Lina Buzermaniene attended a joint meeting of the European Medicines Agency‘s (EMA) Patients and Consumers Working Party (PCWP) and Healthcare Professionals’ Working Group (HCP WG), and the second stakeholder forum on the implementation of the new pharmacovigilance legislation, to become applicable in July 2012 to improve patient safety through better prevention, detection and assessment of adverse reactions to medicines.
At the PCWP/HCP WG meeting, EMA presented its Geriatric Medicines Strategy for the development of medicines for the elderly, and gave an update on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), established to strengthen the postauthorisation monitoring of medicinal products in Europe by facilitating multi-centre, independent, post-authorisation studies focusing on safety, benefit and risk.
Topics at the stakeholders forum on pharmacovigilance included the establishment of the Pharmacovigilance and Risk Assessment Committee (PRAC), the introduction of public hearings, direct reporting of side effects by patients and the development of EudraVigilance (a database for reporting and evaluating adverse effects within the EU).
PRAC will include representatives from each member state and 8 additional expert members in different fields. It will be responsible for providing recommendations on any question relating to pharmacovigilance activities with respect to medicinal products for human use and to risk management systems, and for monitoring these systems’ effectiveness.
Presenting their views, patients representatives stressed that EMA should encourage education programmmes on pharmacovigilance for national patient groups, and provided direct examples of how patient reporting on adverse reactions can bring added value.
See the presentations and meeting report on pharmacovigilance
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