Governance

General Assembly: The General Assembly is composed of all beneficiaries of the EJP RD. The General Assembly will be the ultimate decision making body dealing with extraordinary decision requiring vote of all members like inclusion of new ones or exclusion of a nonperforming partner. For other decisions the vote will be centralized and put in hands of Governing Board. Voting procedure: The GA will strive to reach consensus and if consensus cannot be reached, the GA will vote on different options. GA Quorum and voting arrangements will be elaborated on in the Consortium Agreement.

Governing Board: The Governing Board (GB) is the highest decision making body to approve the organization, work programme, the Annual Work Plan of the following year, the structure and information flow and the political outcome of the EJP RD. The Governing Board consists of one representative per participating country, one representative of ERNs, one representative of participating EU infrastructures, one patient organization representative (EURORDIS), one representative of Orphanet and one representative of other non-profit organizations.

Coordination Office: The Coordination Office based at INSERM consists of the coordinator, two senior and two junior project managers, communication officer, financial officer and assistant. The CO is the central point and carry out the day-to-day operational management by supporting EJP RD partners.

Independent Ethics Advisor: With the aim to comply with the European ethical and legal frameworks, an independent expert is appointed as an “Ethics Advisor” in charge of advising on and monitoring ethical/legal/regulatory issues of the EJP RD, of the Data Management Plan, as well as of the projects founded within EJP RD to ensure that the ethics managementof the projects are carried out within the H2020 framework.

Advisory Regulatory Ethics Board: In order to ensure compliance of the project and its activities with ethical and regulatory requirements, a project ‘Advisory Regulatory Ethics Board’ (AREB) has been set up. It consists of internal EJP RD ethics/regulatory/legal experts, including members with recognised expertise from involved European RIs. It ensures compliance with all international and European relevant rules and ethical norms, including but not limited to fundamental and patients’ rights, data management, protection and confidentiality, of the EJP RD as well as of the projects founded within EJP RD. In particular, the AREB is in charge of overseeing ethical issues and regulatory procedures envisaged in the EJP RD four Pillars and by assisting partners.

● Representatives of national ministries of research and health;
● Representatives of European Commission Directorates: DG RTD, DG Santé, DG Connect;
● Representative of the pharmaceutical industry and public-private initiatives (e.g. European Federation of Pharmaceutical Industries and Associations, EFPIA; Innovative Medicines Initiative, IMI);
● Representative of EuropaBio;
● Representative of regulatory authorities (e.g. European Medicines Agency, EMA, esp. Committee for Orphan Medicinal Products, COMP, EuNetHTA); and
● Chair and vice-chair of the International Rare Diseases Research Consortium (IRDiRC).
Meetings: Once a year

National mirror groups (NMG): Participating countries are strongly advised to constitute NMG, bringing together the national representatives of the EJP RD and other relevant RD stakeholders. The role of the NMGs is to ensure national coordination, contribute to the objectives of the EJP RD and benefit from it. The creation and composition of a NMG is at the discretion of each participating country. NMGs include representatives of the National plan for RD, national nodes of the European Reference Networks, relevant national authorities and research institutions (whether participating to the EJP RD or not), as well as the relevant national partners of the EJP RD and GB member that report NMG views and positions during GB meetings. Although not mandatory, the establishment of National Mirror Groups ensures that national activities, strategies and needs are taken into account when taking decisions at the EJP RD level and when designing the annual work plans. Please see the NMG Terms of Reference and NMG Country examples for more details.

Board of funders: In order to ensure the independence of joint transnational calls management (Pillar 1), the final decisions on call topics and implementation of calls are taken autonomously by the Board of Funders (BOF). The composition of Board of Funders is variable depending on the configuration of funding bodies participating in the joint transnational calls. BOF is chaired by the Pillar 1 leaders.
Meetings: Ad hoc meetings before and after the launch of each joint transnational call for proposals

Ad hoc Advisory Board (AB): The ad hoc Advisory Board(s) is constituted on demand of BOF or Pillar 2 and 4 leaders in relation to pilot projects foreseen. The AB consists of international experts and RD stakeholders to include their knowledge and experience and use their input for the definition of the research strategy for joint transnational calls or pilot projects.