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CORDIS - EU research results
CORDIS

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

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Developing Protocols for conducting performance verification studies (opens in new window)

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 (opens in new window)

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 (opens in new window)

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

Preparation of training curriculum and materials for assessors (opens in new window)

Preparation of training curriculum and materials for assessors will be done

Customization of short ethics course for Rwanda (opens in new window)

Short ethics course will be customized for Rwanda FDA

Launching of the project (opens in new window)

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

Guidelines and SOP for evaluation (opens in new window)

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

Post-marketing protocol and plan developed (opens in new window)

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

Website of the project (opens in new window)

Website of the project will established

Exploitation and Dissemination plan (opens in new window)

Exploitation and dissemination plan developed

Developing guidance documents for conducting performance evaluation (opens in new window)

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

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