Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action.
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 exper...
| Publicado en: | Drug Safety Vol. 41; no. 12; pp. 1285 - 1303 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Springer Nature
Dec2018
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=132904305&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 132904305 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01145916 C5E jtl: Drug Safety issn: 01145916 maglogo: N pubinfo: dt: Dec2018 vid: 41 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 132904305 132904305 NLM30128638 132904305 10.1007/s40264-018-0708-5 NLM30128638 132904305 ppf: 1285 ppct: 18 formats: tig: atl: Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action. aug: au: Radecka, Anna Loughlin, Louise Foy, Mick de Ferraz Guimaraes, Margarida Viana Sarinic, Viola Macolic Di Giusti, Marina Dimov Lesicar, Marina Straus, Sabine Montero, Dolores Pallos, Julia Ivanovic, Jelena Raine, June affil: Medicines and Healthcare products Regulatory Agency (MHRA), London, UK sug: subj: Adverse Drug Event Prevention and Control Adverse Drug Event Legislation and Jurisprudence Legislation, Drug Trends Pharmacovigilance European Union Adverse Drug Event Epidemiology Human Adverse Drug Event Trends Validation Studies Comparative Studies Evaluation Research Multicenter Studies Clinical Assessment Tools Ferrans and Powers Quality of Life Index Scales ab: 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. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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