This module is designed to equip the learner with advanced competencies in designing, conducting, analysis and reporting clinical trials in pharmaceutical and biopharmaceutical development. It will cover different components related to phases of clinical trials, clinical trial types, protocol development, trial design, sample size determination, data management, trial inspection and monitoring and iethical considerations and good clinical practice in implementing clinical trials
The module is composed of 4 unites which introduce students to phases, types and designs of clinical trials, protocol development, sample size determination, data management, oversight of clinical trials, the basic ethical principles and principles and standards of good clinical practice.
- Teacher: Prof. Eyasu Makonnen
- Teacher: Lazare Ntirenganya
This module is designed to equip you with advanced health product regulation competencies.
Brief description of the module: This module will cover different components related to the quality and safety surveillance of pharmaceuticals and biopharmaceuticals. Components such as clinical trial oversight, registration and marketing authorization, and other regulatory functions will also be covered.
- Teacher: Dr Innocent Hahirwa
- Teacher: Dr. TOLESSA Muleta Daba
- Teacher: Dr. Dieudonne Mutangana