Publication: Estudio del marco normativo de los ensayos clínicos en España
Loading...
Files
Official URL
Full text at PDC
Publication Date
2024-03-05
Authors
Advisors (or tutors)
Editors
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Complutense de Madrid
Citations
Exportar
Abstract
La investigación clínica aporta conocimiento médico a través del estudio con medicamentos en personas, siendo el nexo entre la investigación básica y la asistencia a los pacientes. Los datos de este tipo de investigaciones permiten obtener la autorización de comercialización para nuevos fármacos de las diferentes agencias reguladoras. En esta tesis doctoral con mención industrial se revisa la necesidad de la existencia de la investigación clínica, su evolución a lo largo del tiempo, así como el régimen jurídico de la investigación clínica en España en el ordenamiento jurídico español a través de cinco capítulos totalmente diferenciados entre ellos, con un hilo conductor común que busca analizar el desarrollo de la investigación clínica hasta la actualidad, así como de indicarse nuevas posibles áreas de foco y/o mejora en las herramientas jurídicas, o en los procesos llevados a cabo en la investigación clínica...
Clinical Research provides medical knowledge through the study of drugs in human beings, being the link between basic research and patient care. The data from this type of research allows obtaining marketing authorization for new drugs from the different regulatory agencies.This doctoral thesis with industrial mention reviews the need for the existence of clinical research, its evolution over time, as well as the legal regime of clinical research in Spain in the Spanish legal system through five completely different chapters, with a common thread that seeks to analyze the development of clinical research to date, as well as to indicate new possible areas of focus and/or improvement in the legal tools, or in the processes carried out in clinical research...
Clinical Research provides medical knowledge through the study of drugs in human beings, being the link between basic research and patient care. The data from this type of research allows obtaining marketing authorization for new drugs from the different regulatory agencies.This doctoral thesis with industrial mention reviews the need for the existence of clinical research, its evolution over time, as well as the legal regime of clinical research in Spain in the Spanish legal system through five completely different chapters, with a common thread that seeks to analyze the development of clinical research to date, as well as to indicate new possible areas of focus and/or improvement in the legal tools, or in the processes carried out in clinical research...
Description
Tesis inédita de la Universidad Complutense de Madrid, Facultad de Farmacia, leída el 11-07-2023