At the 15th CT-Luso project coordination meeting, held on 3 December, the main developments in legislation, scientific publications, training and capacity-building activities in the field of clinical trials in the Portuguese-speaking African countries (PALOP) were presented. The online meeting was moderated by project coordinator Maria do Céu Patrão Neves.
At the beginning of the meeting, Daniela Marques Dias, from the Centre for Bioethical Law at the University of Coimbra, presented the set of legislative recommendations submitted to the European Commission (Deliverable 3.3) for the ethical and regulatory harmonisation of clinical trials across the Portuguese-speaking countries. This was followed by an update from João Semedo and Eduardo Tavares (Cabo Verde) and Virgílio Uamba (Mozambique) on ongoing legislative developments in their respective countries.
João Semedo noted that the review of the proposed health research law had made significant progress, including strengthened provisions on investigational medicinal products and the creation of national mechanisms such as a database and a platform for the national registration of clinical studies.
Virgílio Uamba added that legislative progress was also being made in Mozambique, particularly regarding medical devices. Miguel Pereira (Guinea-Bissau) also took part in the discussion, briefly noting that developments in his country remain constrained by the current national context.
The CT-Luso project coordinator, Maria do Céu Patrão Neves, then highlighted the publication of the article “CT-Luso: Towards Ethical and Regulatory Harmonisation of Clinical Trials in Portuguese-Speaking African Countries” in Cadernos Ibero-Americanos de Direito Sanitário. The meeting also included a review of the project's first [webinar], dedicated to the theme [“The Importance of Food Sovereignty for Sustainable Development”], held on 19 November, which examined the links between food policies, development and public health.
As part of the training component, the “Good Clinical Practice | ICH-GCP (R3) Guidelines” Training Programme was also highlighted. The programme began on 4 December and is aimed at professionals from medicines regulatory authorities, ethics committees and research teams in the partner countries. Maria Alexandra Ribeiro, CT-Luso project consultant, presented this new training cycle, which has 135 registered participants. The first sessions will be delivered by professionals from CEIC, with contributions at this meeting from Rui Tato Marinho, President of CEIC, and Raquel Silva, Head of the Support Office. This initiative is part of the project's strategy to strengthen technical expertise in the field of clinical research.
