The Chemistry, Manufacturing and Controls section of the sponsor drug submissions to the FDA demonstrate to the FDA the ability to consistently manufacture, store and control the drug product under review. Data included in the CMC section comprises approximately one third of the New Drug Application. This course is designed for technical and regulatory professionals who are or will be involved in the development of new drug candidates. You will learn the practical considerations for achieving CMC objectives from IND through Phase II human clinical studies. The focus will be primarily for biologics drugs as opposed to small molecule drugs, however many of the same principles apply.
Course Number: CHEM-40002 Credit: 1 unit