Curricular training report at risk management directorate

Detalhes bibliográficos
Autor(a) principal: Etelvino, Maira Christiane Socorro Duarte
Data de Publicação: 2014
Tipo de documento: Dissertação
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10773/13994
Resumo: This report is a summary of the activities developed during 9 months of curricular training at the Directorate of Risk Management for Medicines as part of the master degree in Pharmaceutical Medicine. The internship has the purpose of complement the theoretical knowledge previously acquired and was focused on the two areas of the Directorate: Safety Monitoring and Risk Minimization. The activities of the Directorate include the collection and validation of Individual Case Safety Report received from healthcare professionals, patients and pharmaceutical companies. The activities of Risk Minimization include the implementation of safety variations, management of periodic safety update report and risk management plan, validation of the direct healthcare professional communication and the evaluation of educational materials. The Directorate is also responsible to identify and manage safety signals.
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spelling Curricular training report at risk management directorateBiomedicinaFarmacovigilânciaThis report is a summary of the activities developed during 9 months of curricular training at the Directorate of Risk Management for Medicines as part of the master degree in Pharmaceutical Medicine. The internship has the purpose of complement the theoretical knowledge previously acquired and was focused on the two areas of the Directorate: Safety Monitoring and Risk Minimization. The activities of the Directorate include the collection and validation of Individual Case Safety Report received from healthcare professionals, patients and pharmaceutical companies. The activities of Risk Minimization include the implementation of safety variations, management of periodic safety update report and risk management plan, validation of the direct healthcare professional communication and the evaluation of educational materials. The Directorate is also responsible to identify and manage safety signals.Este relatório é o sumário das atividades realizadas durante 9 meses de estágio na Direção de Gestão do Risco de Medicamentos no âmbito do mestrado em Biomedicina Farmacêutica. O estágio teve o objetivo de complementar os conhecimentos teóricos adquiridos e contemplou as duas principais áreas de ação da Direção: a Monitorização de Segurança de Medicamentos de Uso Humano e a Minimização do Risco. De entre as atividades da Direção inclui-se a recolha e avaliação de notificações de reações adversas enviadas por profissionais de saúde, utentes e empresas farmacêuticas. As atividades de minimização do risco associado a medicamentos incluem atividades como as alterações de segurança, a gestão dos relatórios periódicos de segurança e dos planos de gestão do risco, a validação das comunicações dirigidas aos profissionais de saúde e a avaliação dos materiais educacionais. A Direção tem ainda a função de detetar novos sinais de segurança e fazer a sua gestão.Universidade de Aveiro2015-05-05T16:20:23Z2014-01-01T00:00:00Z2014info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10773/13994TID:201583798engEtelvino, Maira Christiane Socorro Duarteinfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-02-22T11:25:31Zoai:ria.ua.pt:10773/13994Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T02:49:41.142200Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Curricular training report at risk management directorate
title Curricular training report at risk management directorate
spellingShingle Curricular training report at risk management directorate
Etelvino, Maira Christiane Socorro Duarte
Biomedicina
Farmacovigilância
title_short Curricular training report at risk management directorate
title_full Curricular training report at risk management directorate
title_fullStr Curricular training report at risk management directorate
title_full_unstemmed Curricular training report at risk management directorate
title_sort Curricular training report at risk management directorate
author Etelvino, Maira Christiane Socorro Duarte
author_facet Etelvino, Maira Christiane Socorro Duarte
author_role author
dc.contributor.author.fl_str_mv Etelvino, Maira Christiane Socorro Duarte
dc.subject.por.fl_str_mv Biomedicina
Farmacovigilância
topic Biomedicina
Farmacovigilância
description This report is a summary of the activities developed during 9 months of curricular training at the Directorate of Risk Management for Medicines as part of the master degree in Pharmaceutical Medicine. The internship has the purpose of complement the theoretical knowledge previously acquired and was focused on the two areas of the Directorate: Safety Monitoring and Risk Minimization. The activities of the Directorate include the collection and validation of Individual Case Safety Report received from healthcare professionals, patients and pharmaceutical companies. The activities of Risk Minimization include the implementation of safety variations, management of periodic safety update report and risk management plan, validation of the direct healthcare professional communication and the evaluation of educational materials. The Directorate is also responsible to identify and manage safety signals.
publishDate 2014
dc.date.none.fl_str_mv 2014-01-01T00:00:00Z
2014
2015-05-05T16:20:23Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
format masterThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10773/13994
TID:201583798
url http://hdl.handle.net/10773/13994
identifier_str_mv TID:201583798
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade de Aveiro
publisher.none.fl_str_mv Universidade de Aveiro
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
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