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dc.contributor.authorPuñal Riobóo, Janet
dc.contributor.authorVarela Lema, Leonor 
dc.contributor.authorGuilhoume, Chantal
dc.contributor.authorGalbraith, Margaret
dc.contributor.authorBelorgey, Chantal
dc.contributor.authorFaraldo Vallés, María José
dc.contributor.authorMeillassoux, Amélie
dc.date.accessioned2022-04-26T12:03:05Z
dc.date.available2022-04-26T12:03:05Z
dc.date.issued2022-04-19
dc.identifier.otherhttps://pubmed.ncbi.nlm.nih.gov/35437135/es
dc.identifier.urihttp://hdl.handle.net/20.500.11940/16564
dc.description.abstractObjectives: The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities. Methods: In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners. Results: Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission. Conclusions: Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.es
dc.language.isoenges
dc.relation.isreferencedbyhttps://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/postlaunch-evidence-generation-practices-among-health-technology-assessment-bodies-in-europe/ECAD80B5C9A72A4D315C9CF5FAB87139es
dc.subject.meshEuropean Union*
dc.subject.meshTechnology Assessment, Biomedical*
dc.titlePostlaunch evidence generation practices among health technology assessment bodies in Europees
dc.typeArtigoes
dc.rights.holderLos autoreses
dc.identifier.pmid35437135
dc.issue.number1es
dc.journal.titleInternational Journal of technology Assessment in Health Carees
dc.organizationServizo Galego de Saúde::Xerencia do Servizo Galego de Saúde::Axencia Galega para a Xestión do Coñecemento en Saúdees
dc.page.initiale33es
dc.relation.publisherversionhttps://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/postlaunch-evidence-generation-practices-among-health-technology-assessment-bodies-in-europe/ECAD80B5C9A72A4D315C9CF5FAB87139es
dc.rights.accessRightsopenAccesses
dc.subject.decsUnión Europea*
dc.subject.decsevaluación de tecnologías biomédicas*
dc.subject.keywordAvalia-tes
dc.subject.keywordEUnetHTA partnerses
dc.subject.keywordEvidence gapses
dc.subject.keywordHealth technology assessmentes
dc.subject.keywordPLEG practicees
dc.typefidesArtigo Científico (inclue Orixinal, Orixinal breve, Revisión Sistemática e Meta-análisis)es
dc.typesophosArtículo Originales
dc.volume.number38es


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