Cluster 6 - Management Activities

WP6.1 General project management activities and governance

Overall governance and ultimate decision-making rests with the EMVDA Steering Committee.

The objectives are to: 1) develop, in close collaboration with EMVDA’s External Scientific Advisory Committee (ESAC), the procedure for project review and decision making by the Steering Committee ; 2) develop the necessary documentation to be submitted to the Steering Committee and ESAC for project review and decision-making; and 3) implement the decisions of the Steering Committee. A product development management structure will be set up for each antigen candidate.

Work Package Leader: EVI 

WP6.2 Product development management & regulatory affairs

The Product Manager, ensures an efficient and timely transfer of vaccine candidates from the preclinical validation stage to cGMP production and clinical phase I testing in European volunteers. The Product Manager follows the development of all products from the initial stages until the successful completion of the envisaged demonstration activities. The Product Manager oversees the design, set-up and the practical implementation of EMVDA's central preclinical assay package.

Work Package Leader: EVI

WP6.3 Ethics issues

All partners have extensive experience in their research area, with proven track records. As a consequence, all partners are aware of and follow the appropriate national and international rules and regulations, as they pertain to access to and use of human blood samples, clinical data and handling of animals. Where national law requires approval from an independent ethical committee or other body, this is obtained. International agreements covering research on human beings are observed and respected. Likewise, European regulations regarding the Protection of Animals used for Experimental and Other Scientific Purposes are respected. Each institution is responsible for the ethical conduct of research undertaken by its staff or students regardless of the location where the research is conducted. Thus, review of research by the relevant Institution Review Board (IRB) is required in addition to review by any agency having jurisdiction over the site of the research. However, in multi-centre research such as that carried out under EMVDA, where several IRB consider the same proposal, different conclusions on one or more aspects of the proposed research may be reached.

Work Package Leader: EVI

WP6.4 Gender issues

The project actively seeks to promote gender equality at all management levels (internally and where appropriate externally, including ESAC) throughout its duration. As a key feature the management oversees gender equality during the lifetime of the project and actively spreads awareness and considerations of the equal needs and interests of both women and men.

Women scientists are encouraged to participate fully in the management framework of the project. As a pivotal role the management organisation and the Coordinator have recruited women for both the Project and Product Managers positions. The management proactively uses its influence to promote specific measures for the integration of more women at the level of Principal Investigator (PI) at research institutions and universities. PIs who are responsible for recruitment of new personnel to the project will be asked to encourage applications from female researchers. It is the responsibility of the EC to promote best employment practice throughout the partners over and above legal requirements.

Work Package Leader: EVI