Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action

Anna Radecka (), Louise Loughlin, Mick Foy, Margarida Viana de Ferraz Guimaraes, Viola Macolic Sarinic, Marina Dimov Giusti, Marina Lesicar, Sabine Straus, Dolores Montero, Julia Pallos, Jelena Ivanovic and June Raine
Additional contact information
Anna Radecka: Medicines and Healthcare products Regulatory Agency (MHRA)
Louise Loughlin: Medicines and Healthcare products Regulatory Agency (MHRA)
Mick Foy: Medicines and Healthcare products Regulatory Agency (MHRA)
Margarida Viana de Ferraz Guimaraes: INFARMED-National Authority of Medicines and Health Products
Viola Macolic Sarinic: World Health Organization (WHO)
Marina Dimov Giusti: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Marina Lesicar: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Sabine Straus: Medicines Evaluation Board (MEB)
Dolores Montero: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Julia Pallos: National Institute of Pharmacy and Nutrition (OGYÉI)
Jelena Ivanovic: Italian Medicines Agency (AIFA)
June Raine: Medicines and Healthcare products Regulatory Agency (MHRA)

Drug Safety, 2018, vol. 41, issue 12, No 3, 1285-1302

Abstract: Abstract In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project evaluated then-current practices and developed tools to further improve the skills and capability in the pharmacovigilance network. The project was divided into eight separate work streams, five of which concentrated on pharmacovigilance topics—collecting information on suspected adverse drug reactions, identifying and managing safety issues (signals), communicating risk and assessing risk minimisation measures, supported by effective quality management systems. The other three work streams focused on the functional aspects—coordination, communication and evaluation of the project. Through the project, SCOPE delivered guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice. The deliverables provide practical guidance that those working in the European national competent authorities can take to strengthen their national systems. The SCOPE outputs can be useful for other stakeholders involved in pharmacovigilance activities, including the pharmaceutical industry, healthcare professionals, patient and consumer organisations, and academia.

Date: 2018
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DOI: 10.1007/s40264-018-0708-5

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