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Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States article annex_III CELEX: 32014D0556 GOVERNANCE OF THE EDCTP2 PROGRAMME
The organisational structure of the EDCTP2 Programme shall be as follows: (1) The EDCTP2-IS shall be governed by a general assembly (‘GA’), in which all Participating States are represented. The GA’s principal responsibility shall be to ensure that all necessary activities are undertaken to achieve the objectives of the EDCTP2 Programme, and that its resources are properly and efficiently managed. It shall adopt the annual work plan. The GA shall decide by consensus. Failing consensus, the GA shall take its decisions by a majority of at least 75 % of the votes. The Union, represented by the Commission, shall be invited to all GA meetings as an observer, and shall receive all necessary documents. It may take part in discussions. |
Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States article annex_III CELEX: 32014D0556 (2) The GA shall appoint a Management Board that shall supervise the secretariat of the EDCTP2-IS (‘SEC’) established by the GA as the executive body of the EDCTP2 Programme. The Management Board shall consist of such number of Board Members as the GA may determine, but not less than five. SEC shall have at least the following tasks: (a) execute the annual work plan; (b) provide support to the GA; (c) monitor and report on the implementation of the EDCTP2 Programme; (d) manage the financial contributions from the Participating States, the Union and any third party, and report on their use to the GA and the Union; (e) increase the visibility of the EDCTP2 Programme through advocacy and communication; (f) liaise with the Commission in accordance with the delegation agreement referred to in Article 7. |
Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States article annex_III CELEX: 32014D0556 (3) A Scientific Advisory Committee (‘SAC’) shall advise the GA on the strategic priorities of the EDCTP2 Programme. The SAC shall be appointed by the GA and consist of European and African independent experts competent in areas relevant to the EDCTP2 Programme, taking into account gender balance. The SAC shall have the following tasks: (a) advise the GA on priorities and strategic needs regarding clinical trials in Africa; (b) advise the GA on the content, scope and dimension of the EDCTP2 draft annual work plan, including diseases covered and approaches to be adopted, from a scientific and technical standpoint; (c) review the scientific and technical aspects of the implementation of the EDCTP2 Programme and deliver an opinion on its annual report. In exercising its tasks, the SAC shall monitor and promote high standards of ethical conduct of clinical trials and engage with vaccine regulatory authorities. The SAC may recommend to the GA the setting up of scientific subcommittees, task forces and working groups. The GA shall establish the number of SAC members, their voting rights and the arrangements for their appointment in accordance with Article 40 of Regulation (EU) No 1290/2013. The GA may set up specialised working groups under the SAC with additional independent experts for specific tasks. |