Foundation of Regulatory Affairs in a Global Environment

CTM502 (Not Liberal Arts) Foundation of Regulatory Affairs in a Global Environment 3 hrs. 3 crs. This course will provide an overview of the responsibility of the US Food and Drug Administration (FDA) and the International Conference on Harmonization, Good Clinical Practice (ICH GCP) in protecting and promoting public health by regulating the drugs, biologics and medical devices in the US and globally. The course will also describe different Code of Federal Regulations applicable to the clinical trial process. Preq: Department permission.