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What we doThe Initiative on Optimising Malaria Lab Assays Evaluation is a three year project within the Framework 7 of the European Commission with fourteen Project partners. The overall goal of this three year project is to develop harmonised assays to facilitate comparison of results and improve decision making on vaccine construct development, product characterisation, down selection of candidates and/or formulation, and clinical development plans. The specific objectives of the initiative are based on the application of a framework approach to a qualified assay:
The project is broken up in eight Work Packages. WP1, WP2 and WP3 cover activites directly related to assay harmonisation. WP4, WP5 and WP6 correspond to the and establishment of a repository capacity for material resources ie, common SOPs, standards and reagents, the development and utilisation of an appropriate data management and statistical analysis plan for project activities, training for assay transfer and trouble-shooting capacity, and regulatory and ethical considerations around assay development and harmonisation. WP7 drives the overall implementation plan including management and coordination activities. WP8 will lead the global coordination with other stakeholders involved in the effort of harmonisation in Malaria vaccine development. |