eCTD submission requirements and software demonstration

The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of contents is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. The eCTD is the standard format used for submitting applications, amendments, supplements, and reports to most of the countries.

Category: Crash Courses
Duration : 3 hours, course would be accessible for 1 month from the date of admission

Learning objectives

eCTD concept, submission checklist, lifecycle management, technical requirements- regulated markets, Study Tagging File, software demonstration 

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry / Anyone willing to understand this topic can enroll.

Syllabus

  • Section 1: eCTD submission and demonstration

    • eCTD submission part 1 60 minutes
    • eCTD submission part 2 110 minutes

Fees : 2360

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    Course Include :
  • Video
  • PDF
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