Medical Writing: Document Submission

CTM513 (Not Liberal Arts) Medical Writing: Document Submission 3 hrs. 3 crs. This course will provide an overview of the basic regulatory and writing skills essential for a medical writer to prepare and submit documents to the appropriate regulatory agencies so that the drug, device or biologics can be approved for clinical studies in humans. It will also explain the importance of interpersonal skill to successfully work in a team with team members of different technical expertise whose contribution is essential to meet the requirement for the approval of the regulatory agency following the submission process. Preq: CTM 507; Department permission.