AVAREF supported Review for Investigational Vaccine under the AVAREF Pilot Network

This scientific advice supported the preparation of the Phase II Larissa II clinical trial protocol for the Rift Valley Fever vaccine candidate

This facilitated registration process supported rapid, aligned evaluation of the Men5V conjugate vaccine in high-risk meningitis belt countries. It applied AVAREF’s reliance model to accelerate access while ensuring rigorous review.

This joint review evaluated the EBO-PEP clinical trial application for Ebola post-exposure prophylaxis across four primary countries, with four additional observer countries. It enabled harmonized assessment of scientific, ethical, and safety considerations for outbreak-relevant research.

This joint review assessed multicountry Clinical trial Master protocols for Filovirus Solidarity and Partners trials, supporting Africa’s preparedness for future filovirus outbreaks.

This meeting reviewed progress of AVAREF’s technical workstreams for 2025 and validated priorities for the second half of the year. It focused on guideline development, pilot implementation, and strengthening regulatory preparedness.

This workshop provided hands-on training on the use of the AVAREF digital platform to facilitate joint reviews and reliance workflows. It aimed to improve reviewer coordination, data sharing, and tracking of multi-country review processes.

This workshop supported African countries in adapting WHO regulatory guidance on human cells, tissues, and advanced therapies. It focused on TRS 1048 Annex 3 and the development of national frameworks for ATMP regulation

This workshop launched the Harmonization Working Group, establishing a collaborative structure to advance regulatory convergence across 16 pilot countries. It initiated a comparative analysis of regulations and processes to support the development of a long-term harmonization roadmap

This facilitated review supported rapid evaluation of the MVA-BN Mpox vaccine dossier for emergency use across 13 African countries. It aimed to ensure harmonized scientific and regulatory conclusions to guide national emergency decisions.

This facilitated review supported synchronized assessment of the R21 malaria vaccine across 22 African countries. It applied reliance principles to accelerate national implementation while maintaining rigorous scientific review.

This joint review evaluated the SMAART-MAP clinical trial application through a harmonized, multi-country process. It enabled coordinated scientific and ethical assessment across six African regulators.

This joint review examined the clinical trial application for a new TB vaccine candidate across four African countries. It aimed to harmonize key scientific, safety, and ethical considerations for trial initiation.

This AC meeting provided strategic guidance on AVAREF’s role in the clinical trial ecosystem in the era of AMA. It reviewed TCC recommendations, endorsed key initiatives, and agreed on priorities for the AVAREF Clinical Trial Pilot Project .

This TCC meeting advanced AVAREF’s technical agenda and prepared recommendations for the Advisory Committee. It focused on the clinical trial pilot project, guideline and tool development, performance metrics, and support to AMA operationalization.

This meeting reviewed progress on AVAREF’s technical programmes for 2023–2024 and validated priorities for the year ahead. It focused on guideline development, joint review processes, and strengthening the reliance mechanisms.

This workshop strengthened the capacity of francophone African regulators to assess clinical trial applications using AVAREF tools and international standards. It focused on non-clinical, clinical, statistical, and quality assessment, as well as GCP, pharmacovigilance, and inspection. .

This workshop strengthened national ethics committees’ capacity to review clinical trials and to use the WHO Benchmarking Tool for Research Ethics Oversight. It combined technical lectures, case studies, and group work to identify gaps, best practices, and priority actions for ethics system strengthening

This regional workshop built the capacity of Southern and Eastern African regulatory reviewers using AVAREF’s harmonized CTA evaluation tools. It combined in-person and virtual sessions with practical dossier-based exercises.

This workshop strengthened the capacity of 3 West African regulators to assess clinical trial applications using AVAREF tools. It provided hands-on training with real dossiers and harmonized evaluation grids

This AVAREF assessment examined Zambia’s clinical trial review and approval system to identify bottlenecks, overlaps, and root causes of long timelines. It aimed to develop concrete actions and a strategic roadmap to optimize regulatory and ethics processes and move toward AVAREF and WHO maturity targets.

This mission assessed Ethiopia’s clinical trial ecosystem to identify strengths, bottlenecks, and opportunities for optimization. It aimed to support the country in improving oversight systems, timelines, and site readiness.