Medical Writing: Investigational Applications For Drugs, Biologics And Medical Devices

CTM514 (Not Liberal Arts) Medical Writing: Investigational Applications For Drugs, Biologics And Medical Devices 3 hrs. 3 crs. This course will provide an overview of a variety of investigational applications prepared by regulatory and medical writers for drugs/biologics and medical devices. Key investigational submissions covered include region-specific applications for drugs/biologics such as the Investigational New Drug Application (IND) in US, Clinical Trial Application (CTA) in Canada and Investigational Medicinal Product Dossier (IMPD) in Europe, as well as those required for investigational devices such as the Investigational Device Exemption (IDE) in US and Investigational Testing Authorization (ITA) in Canada. Components of each of these application types will be discussed. Instructions will be provided on how to write detailed and accurate submission documents. Preq: CTM 507; Department permission.