Lineamientos para investigaciones clínicas en época de COVID-19
Author | Mauricio Patiño/Gerardo Flórez/Diego Quintero |
Position | Socio de PPU experto en procesos judiciales de marcas y patentes/Asociado principal miembro del grupo de Propiedad Intelectual y Ciencias de la Vida/Miembro del grupo de Propiedad Intelectual y Ciencias de la Vida de la oficina de Colombia |
De manera atenta, se les informa que el INVIMA ha dado algunos lineamientos para la presentación y evaluación de estudios del Covid-19.
Así, se tiene que de acuerdo a las Resoluciones 2378 de 2008 y 3823 de 1997, los interesados tienen la obligación de someter a aprobación por parte del Invima los protocolos de investigación con medicamentos que se lleven a cabo en Colombia entre la Fase I y la Fase III intervencionales, los cuales son evaluados por el Grupo de Investigación Clínica del mismo Instituto.
El estudio clínico debe ser evaluado por un Comité(s) de Ética en Investigación adscrito a la certificación en Buenas Prácticas Clínicas de un Centro de Investigación.
Una vez aprobado el estudio clínico por parte del Invima, el responsable del protocolo (Patrocinador/CRO), adquiere el compromiso de reportar semanalmente sobre el estado de avance del mismo.
El investigador debe reportar al Patrocinador o a la Organización de Investigación por Contrato (CRO), al Comité de Ética en Investigación (CEI) todos los eventos adversos serios nacionales, en un plazo no mayor a veinticuatro (24) horas a partir de su conocimiento.
Si desea ampliar tal información y verificar los requisitos, puede dirigirse al siguiente link: https://www.invima.gov.co/web/guest/lineamientos-para-la-presentacion-y-evaluacion-de-estudios-para-covid-19?redirect=%2Fweb%2Fguest%2Fnoticias-2020
Finalmente, queremos resaltar que nuestro equipo de abogados se encuentra laborando remotamente desde sus hogares, en nuestros horarios usuales y disponibles a través de todos los medios virtuales para atender y responder a todas sus necesidades.
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