Publicação
Risk Management Systems - examples of practical implementation
| Resumo: | Purpose To demonstrate the impact of the new legislation of pharmacovigilance in the real-world context by the presentation of practical examples. Methods Critical analysis of the current pharmacovigilance legislation, as well as guidelines and recommendations from the European Medicines Agency (EMA). Results It will be presented a fictitious company risk management system, with its description of the risk management system through the Pharmacovigilance System Master File presentation and a concrete example of a Risk Management Plan of the medicinal product Isotretinoin with detailed implementation proposals of risk minimization measures, in line with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for the recent referral procedure of retinoids. Discussion/Conclusions The new European Legislation in Pharmacovigilance and, consequently, the new regulatory requirements have increased the workload and complexity of pharmacovigilance. The focus of the pharmacovigilance system became a proactive, risk proportionate and patient-centered approach, with high level of transparency and engagement of civil society. This approach brings to fulfil previously unmet medical needs and reducing the burden of adverse drugs reactions by promoting the safeguard public health. |
|---|---|
| Autores principais: | Rodrigues, Patrícia de Lurdes Douteiro |
| Assunto: | Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| Ano: | 2018 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório da Universidade de Lisboa |
| _version_ | 1866809509513527296 |
|---|---|
| author | Rodrigues, Patrícia de Lurdes Douteiro |
| author_facet | Rodrigues, Patrícia de Lurdes Douteiro |
| author_role | author |
| contributor_name_str_mv | Filipe, Hélder Mota Guimarães, Margarida Repositório Científico de Acesso Aberto da ULisboa |
| country_str | PT |
| creators_json_txt | [{\"Person.name\":\"Rodrigues, Patrícia de Lurdes Douteiro\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | Filipe, Hélder Mota Guimarães, Margarida Repositório Científico de Acesso Aberto da ULisboa |
| datacite.creators.creator.creatorName.fl_str_mv | Rodrigues, Patrícia de Lurdes Douteiro |
| datacite.date.Accepted.fl_str_mv | 2018-12-21T00:00:00Z |
| datacite.date.available.fl_str_mv | 2019-11-04T19:47:21Z |
| datacite.date.embargoed.fl_str_mv | 2019-11-04T19:47:21Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| datacite.subjects.subject.fl_str_mv | Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| datacite.titles.title.fl_str_mv | Risk Management Systems - examples of practical implementation |
| dc.contributor.none.fl_str_mv | Filipe, Hélder Mota Guimarães, Margarida Repositório Científico de Acesso Aberto da ULisboa |
| dc.creator.none.fl_str_mv | Rodrigues, Patrícia de Lurdes Douteiro |
| dc.date.Accepted.fl_str_mv | 2018-12-21T00:00:00Z |
| dc.date.available.fl_str_mv | 2019-11-04T19:47:21Z |
| dc.date.embargoed.fl_str_mv | 2019-11-04T19:47:21Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | http://hdl.handle.net/10451/40060 |
| dc.language.none.fl_str_mv | eng |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| dc.subject.none.fl_str_mv | Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| dc.title.fl_str_mv | Risk Management Systems - examples of practical implementation |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_bdcc |
| description | Purpose To demonstrate the impact of the new legislation of pharmacovigilance in the real-world context by the presentation of practical examples. Methods Critical analysis of the current pharmacovigilance legislation, as well as guidelines and recommendations from the European Medicines Agency (EMA). Results It will be presented a fictitious company risk management system, with its description of the risk management system through the Pharmacovigilance System Master File presentation and a concrete example of a Risk Management Plan of the medicinal product Isotretinoin with detailed implementation proposals of risk minimization measures, in line with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for the recent referral procedure of retinoids. Discussion/Conclusions The new European Legislation in Pharmacovigilance and, consequently, the new regulatory requirements have increased the workload and complexity of pharmacovigilance. The focus of the pharmacovigilance system became a proactive, risk proportionate and patient-centered approach, with high level of transparency and engagement of civil society. This approach brings to fulfil previously unmet medical needs and reducing the burden of adverse drugs reactions by promoting the safeguard public health. |
| dirty | 0 |
| eu_rights_str_mv | openAccess |
| format | masterThesis |
| fulltext.url.fl_str_mv | https://repositorio.ulisboa.pt/bitstreams/8d9990aa-088d-4147-b315-42d2fae85a14/download |
| id | ul_5f8343dc873a086e76a8b371663c4302 |
| identifier.url.fl_str_mv | http://hdl.handle.net/10451/40060 |
| instacron_str | ul |
| institution | Universidade de Lisboa |
| instname_str | Universidade de Lisboa |
| language | eng |
| network_acronym_str | ul |
| network_name_str | Repositório da Universidade de Lisboa |
| oai_identifier_str | oai:repositorio.ulisboa.pt:10451/40060 |
| organization_str_mv | urn:organizationAcronym:ul |
| person_str_mv | Rodrigues, Patrícia de Lurdes Douteiro |
| publishDate | 2018 |
| reponame_str | Repositório da Universidade de Lisboa |
| repository_id_str | urn:repositoryAcronym:ul |
| service_str_mv | urn:repositoryAcronym:ul |
| spelling | engpt_PTPurpose To demonstrate the impact of the new legislation of pharmacovigilance in the real-world context by the presentation of practical examples. Methods Critical analysis of the current pharmacovigilance legislation, as well as guidelines and recommendations from the European Medicines Agency (EMA). Results It will be presented a fictitious company risk management system, with its description of the risk management system through the Pharmacovigilance System Master File presentation and a concrete example of a Risk Management Plan of the medicinal product Isotretinoin with detailed implementation proposals of risk minimization measures, in line with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for the recent referral procedure of retinoids. Discussion/Conclusions The new European Legislation in Pharmacovigilance and, consequently, the new regulatory requirements have increased the workload and complexity of pharmacovigilance. The focus of the pharmacovigilance system became a proactive, risk proportionate and patient-centered approach, with high level of transparency and engagement of civil society. This approach brings to fulfil previously unmet medical needs and reducing the burden of adverse drugs reactions by promoting the safeguard public health.application/pdfpt_PTRisk Management Systems - examples of practical implementationRodrigues, Patrícia de Lurdes DouteiroFilipe, Hélder MotaGuimarães, MargaridaHostingInstitutionOrganizationalRepositório Científico de Acesso Aberto da ULisboae-mailmailto:repositorio@reitoria.ulisboa.ptrepositorio@reitoria.ulisboa.ptURNurn:tid:2022517052019-11-04T19:47:21Z2018-12-2120182018-12-21T00:00:00ZHandlehttp://hdl.handle.net/10451/40060http://purl.org/coar/access_right/c_abf2open accessPharmacovigilanceLegislationPharmacovigilance System Master FileRisk management planRisk minimization measuresPRACReferral ProcedureIsotretinoinTeses de mestrado - 20183415103 bytesliteraturehttp://purl.org/coar/resource_type/c_bdccmaster thesishttp://purl.org/coar/access_right/c_abf2application/pdffulltexthttps://repositorio.ulisboa.pt/bitstreams/8d9990aa-088d-4147-b315-42d2fae85a14/download |
| spellingShingle | Risk Management Systems - examples of practical implementation Rodrigues, Patrícia de Lurdes Douteiro Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| status | SINGLETON |
| subject.fl_str_mv | Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| title | Risk Management Systems - examples of practical implementation |
| title_full | Risk Management Systems - examples of practical implementation |
| title_fullStr | Risk Management Systems - examples of practical implementation |
| title_full_unstemmed | Risk Management Systems - examples of practical implementation |
| title_short | Risk Management Systems - examples of practical implementation |
| title_sort | Risk Management Systems - examples of practical implementation |
| topic | Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| topic_facet | Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018 |
| url | http://hdl.handle.net/10451/40060 |
| visible | 1 |