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

The proposed strengthening project for clinical research oversight in ECOWAS region, consists of practical training of regulatory and ethics experts by exposing them to Lassa Fever vaccine development from early to late clinical stage. The exposure to novel technologies in vaccine development and the opportunities to responsibly oversee the full clinical development pathway of vaccines for Africa can inspire and attract regulators and ethics experts/talents, and by this contribute to maintaining, enhancing and further developing the workforce at the agencies and ethics institutions. The project intends to enhance the Maturity Level for Regulatory Systems and clinical trial oversight function of 2-4 authorities in the ECOWAS region. Ghana FDA will lead the intended work, with CEPI as project coordinator, Paul-Ehrlich-Institut as supporting agency and WAHO ensuring the dissemination and engagement among ECOWAS countries. The consortium between GFDA, WAHO, PEI and CEPI is confident to assure high quality regulatory and ethics oversight during Lassa Fever vaccine development and to create preparedness of ECOWAS NRAs not only for Lassa vaccine future licensure but also for decisions related to emergency use in case of a major Lassa Fever outbreak. Using the AVAREF platform for scientific advice and CTA simulations and including ECOWAS observer countries in real live clinical trial application assessments will strengthen the common advice and review processes and lead to reliably generate fast decisions by NRAs and ECs in a seamlessly coordinated way. When processes from application to decision are reliable and fast, developers will prefer using AVAREF platform even for single country clinical trial applications. This will open further possibilities for coordinated involvement of observer countries for training purposes. Seamlessly coordinated collaboration on the basis of harmonized and well-defined processes between NRAs, NECs and AVAREF will promote clinical research in Africa and help the AMA operationalization.