The second level of the Advanced Training Programme dedicated to the ICH-GCP (R3) Good Clinical Practice Guidelines began in February, bringing together around 140 professionals from partner Portuguese-speaking countries. Coordinated by CT-Luso, the initiative is carried out in collaboration with NOVA Medical School, INFARMED, CEIC and CNBS, consolidating a practical approach focused on strengthening institutional capacity in the field of clinical trials.
Organised into three groups (regulatory authorities, ethics committees, and investigators/research centres), participants deepened their knowledge of topics tailored to their professional responsibilities and specific areas of activity. For the regulatory authorities group, the focus was on quality assurance, the importance of transparency in communication and evidence-based decision-making, among other topics. Participants from ethics committees strengthened their knowledge of the protection of vulnerable populations, the need for informed consent in clinical trials, and specific ethical assessment in studies involving medicinal products and medical devices. Meanwhile, investigators and research centre teams reinforced their skills regarding their responsibilities in the conduct of studies, as well as the organisational and infrastructural conditions required to ensure the well-being of clinical trial participants.
This new phase consolidates a training programme focused on the practical application of ICH-GCP (R3) principles, contributing to greater harmonisation of practices and the reinforcement of high standards of ethical and scientific quality.
