Regulatory and Ethics Capacity Building towards Pandemic Preparedness Using an Ecosystem Strengthening Approach
CEPI is excited to announce collaboration with the African Vaccines Regulatory Forum (AVAREF) and funding of the following Capacity Strengthening Project: ‘Regulatory and Ethics Capacity Building towards Pandemic Preparedness Using an Ecosystem Strengthening Approach’. The main objective of this project is to integrate epidemic and/or pandemic preparedness principles, concepts, and practices into regulatory strengthening to further develop the clinical trial ecosystem, enhancing expertise and experience necessary for epidemic/ pandemic preparedness.
The activities are focused on developing the capacity of regulators and ethicists responsible for regulatory and ethics review of clinical trial applications for candidate vaccines and public health priority investigational products. Emphasis is on developing the capacity to review emergency applications utilizing the AVAREF emergency joint review procedure, where countries issue decisions on a clinical trial application within 10 or 15 working days. African countries will gain experience from participating in AVAREF joint reviews, and receive targeted training. This will make the conduct of clinical trials in Africa in the earliest stage of an epidemic or pandemic possible, and will contribute to the feasibility of the 100-day mission through capacity built in the Global South.
It will engage with all the economic regions within Africa where harmonized regulatory systems already exist to varying degrees. The key outcomes of this 2-year program are that regions, and where feasible, countries in Africa will have pandemic ready regulatory systems in place that are robust enough to give continuous science-based advice, oversee clinical trials swiftly, and issue decisions on emergency use authorization, based on incoming data from rolling submissions.
ECOWAS-RegECs Project
Practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fever vaccine development projects and increase regulatory maturity level in targeted countries.
This project (101103241 — ECOWAS-RegECs), which is directed to the Economic Community of West African States (ECOWAS) Member States, is coordinated by CEPI and Funded by the European Union under the Global Health EDCTP3 Joint Undertaking. With CEPI acting as a Project Coordinator, the implementing partners are Food and Drugs Authority, Ghana (G-FDA), West African Health Organization (WAHO), and the Paul Ehrlich Institut (PEI).
The first main objective of the project is to improve the capabilities of Regulators and Ethics Experts in vaccines clinical research oversight, with initial focus on the early stages of vaccine development. For this objective the African Vaccine Regulatory Forum (AVAREF) will be a key partner as we intend to conduct simulations and observations of the AVAREF joint procedures. More specifically, the project team prepares simulation and observation modules making use of applications of Lassa Fever vaccine developers and running them through the AVAREF platform. This will strengthen the ECOWAS Regulators’ and Ethics Experts’ ability to provide scientific advice and assess clinical trial dossiers based on risk-benefit analysis in joint procedures. By exposing National Regulatory Authorities (NRAs) and Ethics Committees (ECs) to the assessment of Lassa Fever vaccines during the vaccine’s development cycle, the project aims to prepare them for licensure and for the case of a possible need for emergency use approval.
This work will promote collaboration between NRAs, ECs and AVAREF for efficient and reliable management of clinical research in West Africa and aims to create a Lassa disease-related regulatory and ethics network.
