PREPARE – Pharmacovigilance, Regulatory and Ethics Preparedness and Response Innovation Network – is one of the newest proposal that we submitted to the European Commission under the Global Health EDCTP3 programme.

It brings together institutions across Zambia, Tanzania, Zanzibar, Uganda, Cameroon and Italy to address a critical challenge for clinical research and medical product safety in sub-Saharan Africa: translating existing regulatory, ethics and pharmacovigilance standards into stronger, sustainable and institutionally embedded systems.

The project proposes an integrated benchmark-to-action approach, connecting WHO-aligned institutional benchmarking with costed development plans, accredited education and competency-based training, expert twinning and supervised practice, harmonised ethics–regulatory pathways, strengthened pharmacovigilance, and secure interoperable digital systems.

A particularly important dimension of PREPARE is preparedness: the consortium aims to strengthen not only routine oversight, but also the capacity of ethics and regulatory systems to respond effectively during public-health emergencies through accelerated review pathways.

PREPARE also looks beyond individual institutions and countries. By connecting Anglophone, Francophone and Lusophone settings, developing multilingual training resources and supporting harmonisation and knowledge exchange, the project aims to create models that can be progressively transferred and scaled across sub-Saharan Africa.

Our thanks go to all consortium partners and colleagues who contributed their expertise, time and commitment to develop and submit this challenging proposal.