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CORDIS - Risultati della ricerca dell’UE
CORDIS

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

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Developing Protocols for conducting performance verification studies (si apre in una nuova finestra)

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 (si apre in una nuova finestra)

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 (si apre in una nuova finestra)

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

Preparation of training curriculum and materials for assessors (si apre in una nuova finestra)

Preparation of training curriculum and materials for assessors will be done

Customization of short ethics course for Rwanda (si apre in una nuova finestra)

Short ethics course will be customized for Rwanda FDA

Launching of the project (si apre in una nuova finestra)

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

Guidelines and SOP for evaluation (si apre in una nuova finestra)

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

Post-marketing protocol and plan developed (si apre in una nuova finestra)

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

Website of the project (si apre in una nuova finestra)

Website of the project will established

Exploitation and Dissemination plan (si apre in una nuova finestra)

Exploitation and dissemination plan developed

Developing guidance documents for conducting performance evaluation (si apre in una nuova finestra)

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

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