The second level of the Advanced Training Programme on the ICH-GCP (R3) Good Clinical Practice Guidelines will begin in February. Lasting approximately four months, this phase is aimed at professionals involved in the assessment, monitoring and conduct of clinical trials, selected through a joint process with the partner countries and coordinated by CT-Luso. With around 140 participants, the initiative involves the Nova Medical School, INFARMED, the Commission for Clinical Research Ethics (CEIC) and the National Bioethics Committee for Health of Mozambique (CNBS). It follows a theoretical and practical approach focused on safety information communication and the application of ICH-GCP (R3) principles in real-world settings.
The participants, from medicines regulatory authorities, ethics committees and research centres/investigator teams, are organised into three distinct groups according to their professional context, with specialised training tailored to each profile. Sessions will take place on different days, Tuesdays, Wednesdays and Thursdays, from 3:15 p.m. to 5:45 p.m., ensuring a structured programme adapted to the needs of each group.
The programme includes theoretical and practical sessions, discussion of real-life situations and collaborative work, including the analysis of practical cases proposed by regulatory authorities, ethics committees and researchers from African countries. In the following months, the focus will shift to the joint development of Standard Operating Procedures (SOPs) and the consolidation of learning, reinforcing an approach based on experience sharing and institutional capacity building.
On 27 January, the session “Safety Assessment and Communication” took place, led by Leonor Nogueira Guerra. The session focused on essential pharmacovigilance concepts in clinical trials, benefit-risk assessment, the European regulatory framework, types of safety reports and communication platforms, as well as the dissemination of safety information through practical examples.
