The purpose of this WP is to strengthen the capacity to conduct preclinical and clinical rigorous studies in the widening countries, including enhancing the core competencies of research personnel, in compliance with the international ethical and regulatory guidelines, as (i) to carry out well-designed and well-conducted preclinical and clinical studies, (ii) to ensure adequate preparedness in accordance with relevant national and international harmonized regulations and standards, (iii) to implement best practices on the efficient and ethical design and conduct of such studies, as well as on how to design, prepare and conduct these studies in collaboration with academic institutions and private sector funding agencies through an active management of conflicts of interests.

The design of the clinical trials must consider the priorities and concerns in terms of public health and health needs of the widening countries, but also the evaluation of the safety and effectiveness of health interventions, aiming to produce practical, statistically robust and scientifically sound evidence needed to guide public health policy, regulatory decisions and medical practices.

Finally, this WP will ensure preparedness to respond to safety events through vaccine-related event (VRE) response planning.