{"id":5190,"date":"2023-12-07T07:49:39","date_gmt":"2023-12-07T12:49:39","guid":{"rendered":"https:\/\/fifarma.org\/?page_id=5190"},"modified":"2024-07-18T12:50:37","modified_gmt":"2024-07-18T17:50:37","slug":"profesionales-y-expertos","status":"publish","type":"page","link":"https:\/\/fifarma.org\/pt\/farmacovigilancia\/profesionales-y-expertos\/","title":{"rendered":"Profesionales y expertos"},"content":{"rendered":"
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RECURSOS PARA<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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profissionais<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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e especialistas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Farmacovigil\u00e2ncia: uma responsabilidade compartilhada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tA farmacovigil\u00e2ncia \u00e9 uma responsabilidade compartilhada entre diversos agentes e entidades que produzem, comercializam e utilizam medicamentos. Para garantir a seguran\u00e7a do paciente, \u00e9 essencial a colabora\u00e7\u00e3o, coordena\u00e7\u00e3o e comunica\u00e7\u00e3o entre todos os atores envolvidos.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Esclare\u00e7a D\u00favidas<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Perguntas frequentes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Esclare\u00e7a D\u00favidas<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Perguntas frequentes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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O que s\u00e3o as diretrizes ICH de farmacovigil\u00e2ncia?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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As Diretrizes ICH (Confer\u00eancia Internacional de Harmoniza\u00e7\u00e3o dos Requisitos T\u00e9cnicos para o Registro de Produtos Farmac\u00eauticos de Uso Humano) s\u00e3o um conjunto de padr\u00f5es e recomenda\u00e7\u00f5es projetados para garantir a qualidade, seguran\u00e7a e efic\u00e1cia dos medicamentos, incluindo aspectos de farmacovigil\u00e2ncia.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Qual \u00e9 o objetivo principal das Diretrizes ICH de farmacovigil\u00e2ncia?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tO objetivo principal \u00e9 o planejamento e a gest\u00e3o de atividades de farmacovigil\u00e2ncia ao longo do ciclo de vida dos produtos farmac\u00eauticos, garantindo uma abordagem baseada na ci\u00eancia para documentar riscos e promover a colabora\u00e7\u00e3o eficaz entre \u00f3rg\u00e3os reguladores e a ind\u00fastria.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Quantas diretrizes existem atualmente que abordam atividades de farmacovigil\u00e2ncia?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Existem seis diretrizes distribu\u00eddas da seguinte maneira:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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<\/i><\/span><\/i><\/span><\/div>
1. Diretrizes para a Gest\u00e3o de Dados de Farmacovigil\u00e2ncia (E2A)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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Esta guia se concentra na gest\u00e3o de dados de seguran\u00e7a cl\u00ednica, estabelece padr\u00f5es e prazos para a apresenta\u00e7\u00e3o de relat\u00f3rios acelerados de rea\u00e7\u00f5es adversas a medicamentos e inclui defini\u00e7\u00f5es de conceitos como Evento Adverso (EA), Rea\u00e7\u00e3o Adversa a Medicamentos (RAM ou SRAM), Rea\u00e7\u00e3o Adversa Inesperada ao Medicamento (SUSAR) e Evento Adverso em Produtos Comercializados.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>

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2. Diretrizes para a Transmiss\u00e3o Eletr\u00f4nica de Relat\u00f3rios de Seguran\u00e7a de Casos Individuais (E2B)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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Esta guia detalha o formato e as normas para a transmiss\u00e3o eletr\u00f4nica do relat\u00f3rio de seguran\u00e7a de casos individuais (ICSR) e o desenvolvimento de padr\u00f5es para a identifica\u00e7\u00e3o de medicamentos (MPID) (ICH M5), facilitando a comunica\u00e7\u00e3o eficiente entre as partes interessadas. Seu uso est\u00e1 focado principalmente na pr\u00e9-comercializa\u00e7\u00e3o e p\u00f3s-comercializa\u00e7\u00e3o dos ICSR e sua informa\u00e7\u00e3o se concentra nos eventos adversos, rea\u00e7\u00f5es dos pacientes e todas as informa\u00e7\u00f5es m\u00e9dicas importantes.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>

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3. Diretrizes para o Relat\u00f3rio Peri\u00f3dico de Avalia\u00e7\u00f5es de Desempenho e Riscos (PBRER) (E2C)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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As intera\u00e7\u00f5es entre medicamentos ocorrem quando dois ou mais f\u00e1rmacos administrados simultaneamente ou em um per\u00edodo pr\u00f3ximo agem de forma conjunta, modificando ou alterando seu efeito original. Essas intera\u00e7\u00f5es podem potencializar, reduzir ou at\u00e9 mesmo neutralizar o efeito de um ou ambos os medicamentos. \u00c9 de vital import\u00e2ncia considerar essa situa\u00e7\u00e3o porque pode levar a efeitos indesejados ou diminuir a efic\u00e1cia do tratamento. Em alguns casos, as intera\u00e7\u00f5es podem ser perigosas e comprometer a sa\u00fade do paciente. Por isso, \u00e9 essencial que os profissionais de sa\u00fade estejam informados sobre todos os medicamentos e suplementos que uma pessoa consome, para prevenir poss\u00edveis eventos adversos.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>

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4. Diretrizes para as Defini\u00e7\u00f5es e Normas de Gest\u00e3o de Dados de Seguran\u00e7a<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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P\u00f3s-Aprova\u00e7\u00e3o para a Apresenta\u00e7\u00e3o de Relat\u00f3rios Acelerados (E2D)\nA E2C oferece diretrizes sobre a elabora\u00e7\u00e3o e apresenta\u00e7\u00e3o do PBRER, um relat\u00f3rio que avalia periodicamente a rela\u00e7\u00e3o benef\u00edcio-risco de um medicamento no mercado, incluindo produtos aprovados que est\u00e3o em fase de estudos adicionais. O objetivo \u00e9 avaliar a seguran\u00e7a e efic\u00e1cia dos produtos farmac\u00eauticos. Esses relat\u00f3rios aplicam-se a diferentes apresenta\u00e7\u00f5es, tais como: (i) subst\u00e2ncias ativas, (ii) produtos combinados e (iii) produtos fabricados e\/ou comercializados por uma empresa.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>

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5. Diretrizes para o Plano de Farmacovigil\u00e2ncia (E2E)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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Este guia se concentra na gest\u00e3o de dados de seguran\u00e7a ap\u00f3s a aprova\u00e7\u00e3o de um medicamento, estabelecendo padr\u00f5es para a apresenta\u00e7\u00e3o de relat\u00f3rios acelerados de eventos adversos e fixando boas pr\u00e1ticas para a gest\u00e3o de dados. Isso inclui a avalia\u00e7\u00e3o de fontes n\u00e3o solicitadas, como relatos espont\u00e2neos e revis\u00f5es de literatura cient\u00edfica.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>

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6. Diretrizes para o Relat\u00f3rio de Atualiza\u00e7\u00e3o sobre Seguran\u00e7a no Desenvolvimento (DSUR) (E2F)<\/div>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
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Este guia aborda o planejamento de atividades de farmacovigil\u00e2ncia ap\u00f3s a comercializa\u00e7\u00e3o de um medicamento, incluindo a avalia\u00e7\u00e3o de riscos e a gest\u00e3o de informa\u00e7\u00f5es atrav\u00e9s do resumo de informa\u00e7\u00f5es relevantes, como riscos importantes, potenciais e informa\u00e7\u00f5es ausentes de um medicamento, incluindo popula\u00e7\u00f5es em risco e situa\u00e7\u00f5es em que medicamentos s\u00e3o usados sem terem sido estudados em uma popula\u00e7\u00e3o. A aplica\u00e7\u00e3o deste guia \u00e9 \u00fatil para entidades qu\u00edmicas, produtos derivados da biotecnologia e vacinas, al\u00e9m de mudan\u00e7as significativas em produtos, novos usos em popula\u00e7\u00f5es, novas indica\u00e7\u00f5es ou surgimento de preocupa\u00e7\u00f5es de seguran\u00e7a relevantes.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Manuais e diretrizes essenciais para farmacovigilantes<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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GU\u00cdAS ICH<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t<\/path><\/svg><\/span>VER RESUMO EM PDF<\/span>\t\t<\/div>\n\t\t
\n\t\t\t<\/path><\/svg><\/span>VER RESUMO EM PDF<\/span>\t\t<\/div>\n\t<\/a>\n<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t<\/path><\/svg><\/span>Ver apresenta\u00e7\u00e3o<\/span>\t\t<\/div>\n\t\t
\n\t\t\t<\/path><\/svg><\/span>Ver apresenta\u00e7\u00e3o<\/span>\t\t<\/div>\n\t<\/a>\n<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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BOAS PR\u00c1TICAS DE FARMACOVIGIL\u00c2NCIA<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t<\/path><\/svg><\/span>Ver apresenta\u00e7\u00e3o<\/span>\t\t<\/div>\n\t\t
\n\t\t\t<\/path><\/svg><\/span>Ver apresenta\u00e7\u00e3o<\/span>\t\t<\/div>\n\t<\/a>\n<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\tUm recurso de:<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Planos de Gerenciamento de Risco<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Import\u00e2ncia dos Planos de Gerenciamento de Risco Associados a Medicamentos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tGarantir a Rela\u00e7\u00e3o Benef\u00edcio-Risco\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tOs planos garantem que os benef\u00edcios de um medicamento sejam maiores que os riscos associados, mantendo a seguran\u00e7a do paciente como prioridade.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMonitoramento Cont\u00ednuo de Seguran\u00e7a\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tPermitem uma vigil\u00e2ncia constante da seguran\u00e7a do medicamento, identificando e gerenciando efeitos adversos ao longo do seu ciclo de vida.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMelhoria na Comunica\u00e7\u00e3o de Riscos\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tFacilitam a comunica\u00e7\u00e3o eficaz dos riscos aos profissionais de sa\u00fade e pacientes, melhorando a tomada de decis\u00f5es informadas.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\tAsseguram o cumprimento das regulamenta\u00e7\u00f5es nacionais e internacionais, mantendo altos padr\u00f5es na ind\u00fastria farmac\u00eautica.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tColabora\u00e7\u00e3o entre Partes Interessadas\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tPromovem a colabora\u00e7\u00e3o entre profissionais de sa\u00fade, reguladores e a ind\u00fastria farmac\u00eautica para uma gest\u00e3o de riscos mais eficaz e coordenada.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t<\/path><\/svg><\/span>Ver apresenta\u00e7\u00e3o<\/span>\t\t<\/div>\n\t<\/a>\n<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t
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Este site de Farmacovigil\u00e2ncia n\u00e3o coleta Relatos de Rea\u00e7\u00f5es Adversas a Medicamentos.
Se voc\u00ea deseja relatar um efeito adverso ou uma queixa t\u00e9cnica sobre um produto farmac\u00eautico, entre em contato com seu profissional de sa\u00fade e\/ou as Autoridades de Sa\u00fade em seu respectivo pa\u00eds.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Vamos nos manter conectados nas redes sociais.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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    \n\t\t\t <\/ul>\n <\/div>","protected":false},"excerpt":{"rendered":"

    RECURSOS PARA Profesionales y expertos Farmacovigilancia: una responsabilidad compartida La farmacovigilancia es una responsabilidad compartida entre diversos agentes y entidades que producen, comercializan y utilizan medicamentos. Para garantizar la seguridad del paciente es esencial la colaboraci\u00f3n, coordinaci\u00f3n y comunicaci\u00f3n entre todos los actores involucrados. ACLAREMOS DUDAS Preguntas frecuentes ACLAREMOS DUDAS Preguntas frecuentes \u00bfQu\u00e9 son las […]<\/p>","protected":false},"author":24,"featured_media":0,"parent":4708,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"enableOnePageScrollInPage":false,"onePageScrollCss":"","onePageScrollSpeed":1000,"onePageScrollAnimation":"easeInOutQuad","onePageScrollShowDotNavigation":true,"onePageScrollNavigation":"scaleUp","onePageScrollNavigationPosition":"right","onePageScrollNavigationHorizontal":[],"onePageScrollNavigationVertical":[],"onePageScrollNavigationSpacing":[],"onePageScrollNavigationColor":"#00ff0d","onePageScrollNavigationColorHover":"#00ff0d","onePageScrollNavigationColorActive":"#00ff0d","onePageScrollNavigationIcon":[],"onePageScrollNavigationWidth":[],"onePageScrollNavigationWidthHover":[],"onePageScrollNavigationWidthActive":[],"onePageScrollNavigationHeight":[],"onePageScrollNavigationHeightHover":[],"onePageScrollNavigationHeightActive":[],"onePageScrollNavigationBorder":[],"onePageScrollNavigationBorderHover":[],"onePageScrollNavigationBorderActive":[],"onePageScrollNavigationBorderRadius":[],"onePageScrollNavigationBorderRadiusHover":[],"onePageScrollNavigationBorderRadiusActive":[],"onePageScrollNavigationTooltipTypography":[],"onePageScrollNavigationTooltipColor":"#ffffff","onePageScrollNavigationTooltipColorHover":"","onePageScrollNavigationTooltipBgColor":"#00ff0d","onePageScrollNavigationTooltipBgColorHover":"","onePageScrollNavigationTooltipPadding":[],"onePageScrollNavigationTooltipPaddingHover":[],"onePageScrollNavigationTooltipBorderRadius":[],"onePageScrollNavigationTooltipBorderRadiusHover":[],"pageSettingsCustomCss":"","footnotes":""},"class_list":["post-5190","page","type-page","status-publish","hentry"],"yoast_head":"\nProfesionales y expertos - FIFARMA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fifarma.org\/pt\/farmacovigilancia\/profesionales-y-expertos\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Profesionales y expertos\" \/>\n<meta property=\"og:description\" content=\"RECURSOS PARA Profesionales y expertos Farmacovigilancia: una responsabilidad compartida La farmacovigilancia es una responsabilidad compartida entre diversos agentes y entidades que producen, comercializan y utilizan medicamentos. Para garantizar la seguridad del paciente es esencial la colaboraci\u00f3n, coordinaci\u00f3n y comunicaci\u00f3n entre todos los actores involucrados. 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