Medical Writing: Document Submission
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Overview
Subject area
CTM
Catalog Number
513
Course Title
Medical Writing: Document Submission
Department(s)
Description
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.
Typically Offered
Fall, Spring
Academic Career
Graduate
Liberal Arts
No
Credits
Minimum Units
3
Maximum Units
3
Academic Progress Units
3
Repeat For Credit
No
Components
Name
Lecture
Hours
3
Requisites
031913