AVAREF-EDCTP Training for Clinical Trial Assessors

AVAREF in collaboration with EDCTP developed a comprehensive training series to provide the necessary training to scientific reviewers within the National Regulatory Authorities (NRAs) to enable them to review clinical trial dossiers.

These courses are offered through the Research Ethics Committees (RECs) to optimise the selection of the right reviewers from the agencies that require the training, encourage the familiarisation of AVAREF tools, guidelines, and processes for clinical trial reviews, and adoption of AVAREF tools.

The trainings are expected to be part of the institutional development plan that would allow the countries to make operational all their regulatory functions.

AVAREF-EDCTP Training for Clinical Trial Assessors within the English-speaking members in East African Communities (EAC) & South African Development Community (SADC) Regional Economic Groups for the NRAs from Botswana, Eswatini, Lesotho, Malawi, Mauritius, Namibia, Seychelles, South Africa, Tanzania, Zambia, Zimbabwe, Ethiopia, Somalia, Kenya, Rwanda, South Sudan, Uganda.

Objectives

The workshop will have the following specific objectives:

• To train selected nominees from EAC and SADC member country Regulatory Authorities on assessment of non-clinical data, clinical trial data, biostatistics data, quality data and emergency use authorization.
• To train selected nominees from EAC and SADC member country Regulatory Authorities on overview of Good Clinical Practice and assessment of safety data from clinical trials
• To facilitate the use of WHO AVAREF documents:  guidelines, tools, guidelines, checklists, and recommendations.
• To sensitize the Regulators and Ethics Committees on the commitment to strengthening the regulatory framework for clinical trials in EAC and SADC member countries.