This consists of 6 modules covering: 1. Regulations for medicinal products. a. History of the development of the regulations. b. Regulatory Submissions for Clinical Trials. 2. Phases of Clinical development. a. Phase II and III. b. Phase IV and Real-World Evidence. 3. Quality in Clinical Trials a. Quality assurance in trials. b. Auditing and Inspection. These modules are prepared for health care professionals’ level 2 beyond the basics and are focused on the requirements and regulations that must be followed for a clinical trial; the phases of clinical trials and the quality that must be assured.
Expected to reach 3-5 billion by 2020 representing half of the world’s population, Africa’s population offers access to drug naïve patients in multiple disease areas as well as an underrepresented demographic in clinical trials. eMQT is uniquely placed as the bridge between the pharmaceutical, Biotechnology and Technology industries and Africa, utilizing research healthcare experts and technology enabled innovation to provide access to patients, high quality evidence based patient data and ultimately patient access to medicines.
