EDCTP Call for Proposals: Ethics and regulatory capacities

The European & Developing Countries Clinical Trials Partnership (EDCTP) opened a call for proposals “Ethics and regulatory capacities” with the purpose to fund projects that are designed to support sub-Saharan African (SSA) countries to establish and/or develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies in humans, as well as national and international collaboration in compliance with established internationally accepted good practices. 

Objectives:

  1. Improve the efficiency of the functioning of NECs and NRAs through the introduction of innovative systems, reliance practices and/or technologies that would facilitate the various functions of these bodies with better quality outputs and improved timelines;
  2. To promote quality control systems and process for NECs and NRAs, as well as certification and accreditation of the various bodies, as well as adherence to international standards;
  3. To promote international cooperation in ethics and regulatory activities through the transfer of promising and successful innovative systems and/or technologies from other regions outside Africa and within Africa, fostering national and regional collaboration among these bodies;
  4. Strengthen linkages between ethics and regulatory functions with other important structures, such as clinical trial registries and systematic reviewers whilst simultaneously enforcing the sharing of data in compliance with global requirements;
  5. Promote the adoption and update of AVAREF, WHO, and other international standards and best practices by countries, groups of countries, or regional harmonisation initiatives;
  6. Support already established training centres to provide both innovative training and mentorship to NECs and NRAs.

Eligibility:

  1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
  2. it complies with the eligibility conditions for participation set out below, depending on the type of action:
    • At least one legal entity established in a Participating State or a sub-Saharan African country. 
    • ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.
    • Applications must include at least one legal entity hosting NECs or NRAs in sub-Saharan African countries.
    • The requested EDCTP contribution per action shall not exceed EUR 500,000.
    • The maximum duration of the project shall be 24 months.

Due to the extraordinary global crisis of COVID-19 that is also affecting African countries, this topic should also be considered by applicants.

Read more here

Proposals deadline July 16, 2020.

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