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CORDIS - Resultados de investigaciones de la UE
CORDIS

Building resilient research ethics, Diagnostics and medicines regulatory capacity during routine and public health emergency periods

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Developing Protocols for conducting performance verification studies (se abrirá en una nueva ventana)

Developing specific protocols for conducting performance verification studies for selected diagnostics test kits used for testing Covid-19, HIV, Hepatitis, Syphilis, TB and Malaria and developing other working tools such as SOPs, flow charts

Training Needs Assessment (se abrirá en una nueva ventana)

Training needs assessment for both therapeutic and vaccines protocol evaluation , and for performance evaluation of in-vitro diagnostics and critical medical devices will be conducted for staff from TMDA, ZFDA, Rwanda FDA, NIMR and ZAHRI

Updated Exploitation and Dissemination Plan (se abrirá en una nueva ventana)

Update the Exploitation and Dissemination Plan as needed during project's progress

Preparation of training curriculum and materials for assessors (se abrirá en una nueva ventana)

Preparation of training curriculum and materials for assessors will be done

Customization of short ethics course for Rwanda (se abrirá en una nueva ventana)

Short ethics course will be customized for Rwanda FDA

Launching of the project (se abrirá en una nueva ventana)

The project will be launched to create awareness on its objectives and other issues pertaining to the project

Guidelines and SOP for evaluation (se abrirá en una nueva ventana)

Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency

Post-marketing protocol and plan developed (se abrirá en una nueva ventana)

Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market

Website of the project (se abrirá en una nueva ventana)

Website of the project will established

Exploitation and Dissemination plan (se abrirá en una nueva ventana)

Exploitation and dissemination plan developed

Developing guidance documents for conducting performance evaluation (se abrirá en una nueva ventana)

Developing guidance documents for applicants and manufacturers on requirements for conducting a performance evaluation of diagnostic test kits

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