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African Vaccine Regulatory Forum Technical Committee (AVAREF-TC)
  • Vision
  • Mission
  • Purpose
  • Scope of Work
  • Objectives
  • Leadership
  • Partners
  • Resources

Vision

An African population that has timely access to safe and efficacious medical products of assured quality.

Mission

To strengthen ethics and regulatory capacity for clinical trials ensuring oversight of product development in African countries.

Purpose

  1. Members shall commit to harmonization, convergence, competence, collaboration and reliance.

  2. Members shall adhere to confidentiality standards to ensure the integrity of data, information, and decisions.

  3. Members shall use the platform to enhance their capacity through discussion, advancement of knowledge and exposure to policies and procedures pertaining to regulatory and ethics oversight.

  4. Members shall jointly develop guidelines, policies, and regulatory frameworks for adoption, adaptation, and implementation in their countries for the ethics and regulatory oversight of clinical trials.

  5. The mandate, mission, objectives, and agenda of AVAREF shall be determined by its membership and governing bodies.

Scope of Work

AVAREF will expand its responsibilities and activities in a step-wise manner from vaccines to include all medical products and geographically to include all African countries. As such, AVAREF represents the first pan-African medical products regulatory network in fulfilment of the goals of AMRH, the AUC and the African Medicines Agency (AMA).

Objectives

The objectives of AVAREF, are as follows:

  • To effectively provide timely and relevant information to African countries which are targeted for clinical trials of medicines, and updates on clinical development of relevant products.

  • To provide expertise to and to enhance capacity for African NRAs and Ethics Committees in support of regulation and evaluation of medical products, including facilitating the development of procedures for the authorization and monitoring of clinical trials as well as the evaluation of clinical trial data.

  • To provide a platform for effective promotion of the principles of pan-African harmonization, convergence, competence-building, collaboration and reliance.

  • To enhance the timeliness and improve the quality of reviews for clinical trail applications to meet internationally competitive standards.

  • To promote innovation and research in Africa for diseases disproportionately affecting Africans.

  • To promote and strengthen communication and collaboration between NRAs in countries where medical products are developed (Europe, North America etc.) and ECs and NRAs in those countries that are targets for clinical trials on the African continent.

  • To provide a platform for effective integration of ethics review into regulatory oversight

  • To serve as basis for advocacy for the sustainability of AVAREF through mobilization of national (local) resources.

  • To harmonize regulation of clinical trials in the African region and improve the safety, efficacy, and quality of medical products.

Leadership

Bodies of the AVAREF

The bodies of the AVAREF are:

  1. the Assembly as a session of AMRC for meeting of heads of NRAs & ECs in Africa

  2. the Steering Committee

  3. the Technical Coordinating Committee, members of which will serve as the Working committee for clinical trials, Working Committee for emergency use of products and other working committees if needs arise

  4. the Secretariat

Mrs. Delese Mimi Darko
Mrs. Delese Mimi Darko
The Chairperson, AVAREF Steering Committee

Chief Executive, Food and Drugs Authority, Ghana

Partners

Bill & Melinda Gates Foundation
US FDA
Paul-Ehrlich-Insitut
Wellcome Trust​
AUDA-NEPAD
EDCTP
CEPI
MRCT Center of Brigham and Women's Hospital and Harvard​
EDCTP​
Africa CDC​​
African Academy of Sciences​​

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Resources

Africa Medical Devices Forum (AMDF) - Technical Committee under the AMRH Initiative
Africa Medical Devices Forum (AMDF) - Technical…

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