Many regulatory agencies are now adapting the electronic Common Technical Document format for application of marketing authorization. Many sponsors are also switching from the paper submission to the electronic Common Technical Document format.We expect that the electronic Common Technical Document will soon be compulsory. It will be a challenge to sponsors who don’t prepare to transition to the electronic Common Technical Document early. This course was designed to meet the need of pharmaceutical companies who realize the need to this training
This training course was designed for personnel dealing with biopharmaceuticals and pharmaceuticals and plan to develop submissions using the eCTD.
You will benefit if you are interested in understanding of essential guidelines, tools, and the required submission processes. It’s highly recommended for all the following :
• Authors of CTD Sections
• Technical Writers
• Clinical Writers
• Regulatory Affairs
• Regulatory Operations personnel
• Submissions Management
• Regulatory affairs Project Managers
• Information Technology personnel
Total Length of Course: 25 hours
Electronic common document
This course is designed for personnel who want to have a good understanding of the eCTD . As most of the information is based on guidelines and regulations, a good command of English language is required.
The course consists of the following topics:
The CTD format
Module 4 and 5
Module 1 EU
Module 1 Canada
On completion of this course you will be able to do the following:
Describe the purpose and scope of the CTD format
Create publishing templates with correct, headers, footers, margins and fonts
Explain the benefits of eCTD to sponsors and regulatory agencies
Understand the information contained in each folder and sub-folder as well as the naming of files
Understand organization of CTD modules 2-5
Apply the eCTD backbone specifications
Understand the leaf elements and the significance of the attributes
Understand the eCTD architecture
Describe the eCTD publishing process and the quality control measures
Describe the regional differences in Module 1 of EU, USA and Canada
This course is Instructor-led and is delivered through our secure student friendly online Learning Management System.
There is a one day in-class training for those who live in the GTA.
. The course consists of 8 topics and Students will be expected to complete one quiz and one homework assignment per topic. Students will also be graded on forum participation in each topic. There will be one final course examination.