Clinical research in a pharmaceutical industry

Detalhes bibliográficos
Autor(a) principal: Ferrão, Ângela Filipa Machado
Data de Publicação: 2015
Tipo de documento: Dissertação
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10773/14880
Resumo: This training report describes the knowledge and experience gained during the curricular internship at the Medical Affairs unit of the Research Department of Bluepharma Indústria S.A.. The main activities addressed are related with the conduction of phase I clinical trials by a sponsor, namely bioequivalence clinical trials. In this context, is described the main applicable regulations, the management process of a clinical trial and a reflection about the main challenges in the field. Furthermore, are outlined the activities related with the management of Research, Development and Innovation projects, particularly the analysis of ideas of new pharmaceutical products, where I contribute with several researches. This first contact with the pharmaceutical industry allowed me to integrate the knowledge and skills gained in the Pharmaceutical Sciences degree with those gained in the master’s course of pharmaceutical medicine, fulfilling one of the main objectives that I define for myself: the growth and acquisition of skills, coupled with the access to a different professional reality.
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spelling Clinical research in a pharmaceutical industryBiomedicina farmacêuticaEnsaios clínicosFarmacologia clínicaThis training report describes the knowledge and experience gained during the curricular internship at the Medical Affairs unit of the Research Department of Bluepharma Indústria S.A.. The main activities addressed are related with the conduction of phase I clinical trials by a sponsor, namely bioequivalence clinical trials. In this context, is described the main applicable regulations, the management process of a clinical trial and a reflection about the main challenges in the field. Furthermore, are outlined the activities related with the management of Research, Development and Innovation projects, particularly the analysis of ideas of new pharmaceutical products, where I contribute with several researches. This first contact with the pharmaceutical industry allowed me to integrate the knowledge and skills gained in the Pharmaceutical Sciences degree with those gained in the master’s course of pharmaceutical medicine, fulfilling one of the main objectives that I define for myself: the growth and acquisition of skills, coupled with the access to a different professional reality.O presente relatório de estágio propõe-se relatar o conhecimento e a experiência adquirida durante o estágio curricular no setor de Assuntos Médicos do departamento de Investigação da Bluepharma Indústria, S.A.. Nele são abordadas as principais atividades realizadas, inerentes à condução de ensaios clínicos de fase I por parte de um promotor, nomeadamente de ensaios de bioequivalência. Neste contexto é feita uma descrição da legislação aplicável, do processo de gestão de um ensaio clínico e uma reflexão acerca dos principais desafios nesta área. Para além disso, são também descritas atividades relacionadas com a gestão de projetos de Investigação, Desenvolvimento e Inovação, particularmente na análise de ideias de novos produtos farmacêuticos para as quais contribuí com diversas pesquisas. Este meu primeiro contacto com a indústria farmacêutica permitiu-me integrar os conhecimentos e competências da licenciatura em Ciências Farmacêuticas com os adquiridos no mestrado de Biomedicina Farmacêutica, cumprindo um dos principais objetivos que estabeleci para mim: o do crescimento e aquisição de competências aliado ao acesso a uma diferente realidade profissional.Universidade de Aveiro2015-11-13T15:06:16Z2015-01-01T00:00:00Z2015info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10773/14880TID:201566613engFerrão, Ângela Filipa Machadoinfo: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:RCAAP2024-02-22T11:27:20Zoai:ria.ua.pt:10773/14880Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T02:50:22.153009Repositório 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 Clinical research in a pharmaceutical industry
title Clinical research in a pharmaceutical industry
spellingShingle Clinical research in a pharmaceutical industry
Ferrão, Ângela Filipa Machado
Biomedicina farmacêutica
Ensaios clínicos
Farmacologia clínica
title_short Clinical research in a pharmaceutical industry
title_full Clinical research in a pharmaceutical industry
title_fullStr Clinical research in a pharmaceutical industry
title_full_unstemmed Clinical research in a pharmaceutical industry
title_sort Clinical research in a pharmaceutical industry
author Ferrão, Ângela Filipa Machado
author_facet Ferrão, Ângela Filipa Machado
author_role author
dc.contributor.author.fl_str_mv Ferrão, Ângela Filipa Machado
dc.subject.por.fl_str_mv Biomedicina farmacêutica
Ensaios clínicos
Farmacologia clínica
topic Biomedicina farmacêutica
Ensaios clínicos
Farmacologia clínica
description This training report describes the knowledge and experience gained during the curricular internship at the Medical Affairs unit of the Research Department of Bluepharma Indústria S.A.. The main activities addressed are related with the conduction of phase I clinical trials by a sponsor, namely bioequivalence clinical trials. In this context, is described the main applicable regulations, the management process of a clinical trial and a reflection about the main challenges in the field. Furthermore, are outlined the activities related with the management of Research, Development and Innovation projects, particularly the analysis of ideas of new pharmaceutical products, where I contribute with several researches. This first contact with the pharmaceutical industry allowed me to integrate the knowledge and skills gained in the Pharmaceutical Sciences degree with those gained in the master’s course of pharmaceutical medicine, fulfilling one of the main objectives that I define for myself: the growth and acquisition of skills, coupled with the access to a different professional reality.
publishDate 2015
dc.date.none.fl_str_mv 2015-11-13T15:06:16Z
2015-01-01T00:00:00Z
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dc.publisher.none.fl_str_mv Universidade de Aveiro
publisher.none.fl_str_mv Universidade de Aveiro
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