MRM 503: Fundamentals of Device & Drug Development

This course provides a broad exposure to introduction to pharmaceutical industry, process of drug development, and drug development phases (1-4). Regulatory requirements of the Saudi Food and Drug Administration (SFDA) and FDA are reviewed along with the content of the investigational new drug application (IND), new drug application (NDA), marketing authorization application (int’l), and the pharmaceutical regulatory affairs. The course emphasis will be on drug development in addition to development of biologics, OTC, and devices. This course focuses on drug discovery through IND submission and clinical development including portfolio decision-making. The roles and responsibilities of the principal investigator, coordinator, sponsor, and monitor are discussed.