The governance structure of PROMISE has been devised to respond to the needs of the project, its size and complexity. It has been designed to steer the efforts optimally towards the desired results, promote scientific discussion and consensus and provide a structure for efficient decision-making. This structure has a balanced representation of all partners involved in the public-private Consortium, together with a variety of decisive affiliated partners.

PROMISE brings together a diverse group of stakeholders, including academia, (national) public health agencies, pharmaceutical industries, patient groups, and clinical societies that have a common goal: alleviating RSV disease burden. The figure below shows the elements of the management structure and how they interconnect.

PROMISE Forum (PF): composed by project partners and Affiliate Partners. Forum for discussion, dissemination and scientific community building within the project.

General Assembly (GA): Project partners, with the ultimate decision-making responsibility in matters affecting the overall project strategy and composition of the consortium.

Steering Committee (SC): Leadership team with 50/50 vote allocation between EFPIA and public beneficiaries composed of both academic and EFPIA WP Leaders or their designated representative. The SC is responsible for decision making on most issues related to project execution, technical development decisions, work plan updates, and effort/budget reassignment in order to pursue optimal efficiency, and full alignment with RESCEU. The SC has oversight of the interactions with EMA and other regulatory agencies.

Operations Team (OT): Executive group composed of the (Co-)Coordinator, the Project Leader and the Project Manager (but not restricted to those), responsible for the day-to-day operational and technical aspects of the project. The OT supports the SC at management and operational levels.

Advisory Boards: consultative bodies for ethical, scientific and technical matters.

  • International Scientific Advisory Group (ISAG)
    ISAG has been established to advise the General Assembly and the Steering Committee as decision making support. This group will provide additional independent expertise and knowledge on scientific and technical matters that can inform the Action approach and strategies.
  • Ethics Advisory Board (EAB)
    An Independent Advisory Ethics Board has also been established to monitor ethic matters and how they are handled. The Board is consulted about various issues regarding PROMISE studies, including children, clinical studies and biobank, data protection as well as qualitative research.
  • Patient Advisory Board (PAB)
    The Patient advisory board will be supporting the Independent Ethics Advisory Board in the monitoring and handling of any ethic issues in PROMISE and safeguarding the protection of study participants, patients data protection. The PAB will also approve the meeting minutes with the EAB, etc.