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CORDIS - Resultados de investigaciones de la UE
CORDIS

Practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fever vaccine development projects and increase regulatory maturity level in targeted countries

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

1st SC meeting and Progress Report (se abrirá en una nueva ventana)

Half-yearly SC meetings are planned to be conducted in virtual remote setting. The SC will be overseeing and supporting the project to ensure the attainment of the milestones and objectives according to plan and should be instrumental to resolve possible challenges during the project.The half yearly project progress report should be presented at the SC meeting by the Project Coordinator.

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

A communication plan will define ways and frequency to communicate projectprogress and what dissemination, exploitation and communication measures will be applied to the results.

2nd SC meeting and Progress Report (se abrirá en una nueva ventana)

Half-yearly SC meetings are planned to be conducted in virtual remote setting. The SC will be overseeing and supporting the project to ensure the attainment of the milestones and objectives according to plan and should be instrumental to resolve possible challenges during the project.The half yearly project progress report should be presented at the SC meeting by the Project Coordinator.

Training roadmap agreed (se abrirá en una nueva ventana)

CEPI in very close collaboration with GFDA and PEI:Develop and agree on a training roadmap, including training concept and process for the LASSA project with stakeholders (AVAREF, interested countries NRA and EC representatives, developers, facilitators).

Develop project Charter, project plan and communication plan (se abrirá en una nueva ventana)

Roles, responsibilities, and foreseen ways of interaction and collaboration between project team, supporting organizations and SC will be outlined in the Project Charter.

Kick-off meeting (project documents, project team and SC in place) (se abrirá en una nueva ventana)

CEPI will arrange for proper project coordination, management, and governance. A project plan with milestones and timelines will be generated, a core project team established, and a Steering Committee proposed. The project plan and team will be validated in the kick-off meeting with the consortium partners and supporting organizations and the SC will be agreed upon. The project kick-off meeting is planned to be held in person.

Consultant hired (se abrirá en una nueva ventana)

Hire consultant for mapping and selection exercise (GFDA has the responsibility to oversee the work of the consultant)

Participation of developers and external experts secured (se abrirá en una nueva ventana)

CEPI in very close collaboration with GFDA and PEI:Secure and plan participation of developers and external experts (e.g., PEI, other EU NRAs, European ethics experts) and shape an aligned plan for their participation.

Countries for ML enhancement selected (se abrirá en una nueva ventana)

WAHO in very close collaboration with GFDA and PEI:Selection of the most eligible candidates for ML enhancement:WAHO will develop a consolidated long term regional plan for regulatory Maturity Level development for the ECOWAS region. Based on the plan, the criteria for selection of the most eligible candidates (anchor countries) will be established by WAHO in consultation with key stakeholders (Ghana FDA, NAFDAC, Senegal Health Research Authority). The subsequent selection will be validated by the project team and steering committee.

WAHO website update with details of the project (se abrirá en una nueva ventana)

A communication plan will define ways and frequency to communicate project progress.The communication plan will contain the following deliverable:WAHO website update with details of the project

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