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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_II

CELEX:  32014D0556

ACTIVITIES AND IMPLEMENTATION OF THE EDCTP2 PROGRAMME (1) Activities The EDCTP2 Programme shall include the following activities:
(a) promoting networking, coordination, alignment, collaboration and integration of national research programmes and activities on poverty-related diseases, including neglected ones, at scientific, management and financial level;
(b) supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, tuberculosis and other poverty-related diseases, including neglected ones;
(c) fostering capacity development for clinical trials and related research in developing countries, in particular in Sub-Saharan Africa, through grants for: career development of junior and senior fellows, promoting mobility, staff exchange grants, research training networks, strengthening ethics and regulatory bodies, mentoring and partnerships at individual or institutional or regional level;
(d) establishing cooperation and launching joint actions with other public and private funders;
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_II

CELEX:  32014D0556

(e) assuring awareness, endorsement and acknowledgment of the EDCTP2 Programme and its activities through advocacy and communication, not only at Union level and in developing countries, but also at global level.
(2) Programme definition and implementation The EDCTP2 Programme shall be implemented by the EDCTP2-IS on the basis of an annual work plan and a multiannual strategic work plan prepared by the EDCTP2-IS, in consultation with the relevant stakeholders, and adopted by the General Assembly of the EDCTP2-IS following international peer-review and subject to the prior approval by the Commission. The annual work plan shall identify topics and activities to be implemented, including calls for proposals to be launched by EDCTP-IS to select and fund indirect actions, as well as the budgets and EDCTP2 funding for those topics and activities. Where appropriate, EDCTP2 may exchange information with other public or private initiatives, including those under Horizon 2020. The annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues.
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_II

CELEX:  32014D0556

The multiannual strategic work plan shall set a common strategic research agenda which shall be prepared and updated on an annual basis. EDCTP2-IS shall monitor the implementation of the activities included in the work plan, including indirect actions selected through calls for proposals it manages. It shall allocate and manage funding to those in accordance with this Decision and the effective implementation of activities selected and identified in the previous work plans.
(3) Deliverables expected from the implementation of the EDCTP2 Programme An annual report shall be provided by the EDCTP2-IS, which shall give a detailed overview of the implementation of the EDCTP2 Programme. That overview shall provide information on each activity selected in accordance with the work plan, including indirect actions selected through calls for proposals managed by the EDCTP2-IS. Such information shall include a description of each activity, including indirect action, its budget, the value of the funding allocated to it if any, and its status.
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_II

CELEX:  32014D0556

With regard to calls managed by the EDCTP2-IS, the annual report shall moreover include information on the number of projects submitted and selected for funding, the detailed use of the Union’s financial contribution, the distribution of national and other contributions including specification on the type of in kind contributions, the types of participants, country statistics, brokerage events and dissemination activities. The annual report may also include, when appropriate, information on measures taken to facilitate access to products stemming from EDCTP2. The annual report shall also include information on the progress towards achieving the EDCTP2 Programme objectives set out in Annex I. In addition, the EDCTP2-IS shall provide any report and information foreseen by this Decision and the agreement concluded with the Union.