FDA and the Electronic Common Technical Document (eCTD)

RGA 6207 4 Quarter Hours
Course Level CPS - Graduate
Description The Common Technical Document (CTD) structure is the mandatory format for new drug applications (NDA) in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the US Food and Drug Administration (FDA). The CTD format was co-internationally developed to assemble all Quality, Safety and Efficacy related information in a common format. It has eliminated the need to restructure the aforementioned information for submission to various International Conference on Harmonization (ICH) regulatory authorities. As of May 2017 NDA, ANDA, BLA and Master File documentation must be submitted to FDA in a standard electronic CTD (eCTD) format. In addition, beginning in May 2018 all commercial IND submissions to FDA must also be filed in eCTD publishing format. This course studies the structure of CTD format documents through study of both regulatory requirements as well as example submissions. In addition, students have an opportunity to develop an understanding of FDA’s eCTD submission requirements. The course curriculum also reviews the basic structure and format of an eCTD submission and the differences between the electronic format and paper based CTD submissions.

Prerequisites

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

 

Course Sections

Section 01
CRN 20894
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Darin Oppenheimer
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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