Regulatory Writing: New Drug Applications

TCC 6380 4 Quarter Hours
Course Level CPS - Graduate
Description Examines the process of writing drug submissions for regulatory agencies both nationally and internationally. Topics include drug regulations, the drug development process, and clinical study documents. Offers students an opportunity to practice communicating complex scientific information in various documents, including investigators’ brochures, clinical trial reports, and IND/NDA submission components.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
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