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Gestão dos processos inerentes à implementação e condução de ensaios clínicos de fase I
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Abstract(s)
O seguinte relatório aborda a importância dos ensaios clínicos para a inovação terapêutica. O desenvolvimento de novos fármacos é um processo demorado e complexo, sendo dividido em etapas. O estágio curricular realizado na BlueClinical Fase I permitiu a integração na esquipa de Gestão de Ensaios Clinícos, possibilitando uma melhor compreensão no que toca á realização de ensaios clínicos. O principal objetivo do presente relatório é fornecer uma visão das atividades realizadas e envolvidas na condução de um ensaio clínico e na importância de garantir a eficácia e segurança da entrada de novos fármacos na indústria estando descritos as diversas etapas pelo que os ensaios clínicos necessitam passar, por que leis e normas são regidos para que seja garantida a qualidade e confiabilidade dos dados submetidos às alteridades regulamentares.
The following report addresses the importance of clinical trials for therapeutic innovation. The development of new drugs is a time-consuming and complex process, divided into stages. The curricular internship carried out at BlueClinical Phase I allowed integration into the Clinical Trials Management team, enabling a better understanding when it comes to carrying out clinical trials. The main objective of this report is to provide an overview of the activities carried out and involved in conducting a clinical trial and the importance of ensuring the effectiveness and safety of new drugs entering the industry, describing the various stages that clinical trials need to go through, why laws and standards are governed to guarantee the quality and reliability of data subject to regulatory changes.
The following report addresses the importance of clinical trials for therapeutic innovation. The development of new drugs is a time-consuming and complex process, divided into stages. The curricular internship carried out at BlueClinical Phase I allowed integration into the Clinical Trials Management team, enabling a better understanding when it comes to carrying out clinical trials. The main objective of this report is to provide an overview of the activities carried out and involved in conducting a clinical trial and the importance of ensuring the effectiveness and safety of new drugs entering the industry, describing the various stages that clinical trials need to go through, why laws and standards are governed to guarantee the quality and reliability of data subject to regulatory changes.
Description
Keywords
Ensaio clínico BlueClinical CTA Clinical trial
Pedagogical Context
Citation
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CC License
Without CC licence