The Côte d’ivoire Ethics Capacity Building Initiative (CECaBI) is a consortium of different partners whose objectives are to strengthen the knowledge and skills of the senior members of the National Ethics Committee for Life Sciences and Ivorian Authorities of Pharmaceutical Regulation (Autorités Ivoiriennes de Régulation Pharmaceutique (AIRP)), on how to conduct high-quality ethics reviews, ensure optimal protection of research participants, and effectively manage and coordinate clinical trials.
Pharmalys is part of this initiative. As such, Karim Bagaté, Director of Clinical Operations & Safety delivered a capacity building programme in Côte d’Ivoire in 2023. The training was delivered in two parts. The first one, in March 2023, was about the Good Clinical Practice (GCP) guidelines and site inspection. The second part, in October 2023 was a refresher on GCP with very practical exercises and workshops and a site inspection visit.
Case study: Turning an eTMF health check into a clear path to inspection readiness
Overview An international vaccine-development organisation engaged Pharmalys to conduct an independent health assessment of the electronic Trial Master File for an ongoing clinical study. The assessment covered approximately 800 documents maintained in an eTMF...
