A meeting held on 6 January 2025 between CT-Luso, the Commission for Clinical Research Ethics (CEIC), INFARMED and the National Bioethics Committee for Health of Mozambique (CNBS) focused on preparing the second phase of the Work Package 5 (WP5) training programme, dedicated to the [Good Clinical Practice Guidelines – ICH-GCP (R3)].
The meeting was attended by Helder Mota Filipe and Catarina Sobrinho (CT-Luso), Pedro Barata and Raquel Silva (CEIC), Marta Marcelino, Joel Passarinho, Fátima Ventura, Ana Rita Martins, Sílvia Correia and Anabela Martinez (INFARMED), as well as Esperança Sevene, representing the CNBS of Mozambique.
The meeting focused on the organisation and structure of the specialised component of the WP5 training programme, led by CEIC and CNBS. In this new phase, participants will be divided into three distinct groups — Regulatory Authorities, Ethics Committees, and Investigators/Research Centres — and will receive specialised training tailored to their respective roles, in line with the requirements and principles of the R3 version of the Good Clinical Practice Guidelines.
During the meeting, the proposed curriculum for the specialised training was presented and will now be reviewed by the participating institutions. The training programme will run until June 2026, combining theoretical and practical sessions, case discussions and the development of training materials, with the aim of strengthening the technical, ethical and regulatory capacity of the different stakeholders involved in the clinical research system.
The meeting helped consolidate alignment among the partner institutions and ensure a coordinated approach focused on the practical implementation of the ICH-GCP (R3) Guidelines, in line with the objectives of the CT-Luso Project.
