On 22 September, CT-Luso presented at the Science Summit 2026, in New York, the results of its work to strengthen ethical review and regulatory capacity for clinical research in Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Helder Mota Filipe, President of the Portuguese Pharmaceutical Society and Project Coordinator, and Esperança Sevene, Scientific Coordinator, took part online in the session organised by Global Health EDCTP3, held on the sidelines of the 81st United Nations General Assembly.

In his presentation, Helder Mota Filipe explained how CT-Luso combines the strengthening of legal frameworks with capacity building for institutions and professionals. The project analysed the legislation governing clinical research in the five countries, identified gaps and developed recommendations setting out priorities, responsibilities and implementation timelines. The proposals are tailored to each country’s situation: while Guinea-Bissau and São Tomé and Príncipe need to develop specific legal frameworks, in Angola, Cabo Verde and Mozambique the focus is primarily on consolidating and improving existing frameworks.

Esperança Sevene presented the project’s training pathway and the results of its first two programmes, which have now been completed. The first, dedicated to the ethical, scientific, legal and regulatory foundations of research, certified 234 professionals. The second focused on Good Clinical Practice and the specific competencies of regulatory authorities, ethics committees and investigators, certifying 87 professionals. Training will continue with an in-person practical component, scheduled to take place in Lisbon from 8 to 14 November. At a later stage, a clinical trial simulation is planned, enabling trained professionals to apply together the skills acquired throughout the project.

The coordinators also highlighted the transition from training to institutional practice. CT-Luso has developed ethical and regulatory assessment templates, standard operating procedures, checklists and other tools to support the work of regulatory authorities, ethics committees and research centres. These materials are intended to make the assessment and monitoring processes for clinical trials clearer and more coordinated.

The presentation was part of the event “Advancing Science: Shaping Clinical Research Across Africa and Beyond”. The meeting brought together international projects and experts to discuss the conditions needed to advance clinical research in Africa and priorities beyond 2030.

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