eCTD Submission Certification Program - Part Time/Distance learning

Global Institute of Regulatory Affairs
In Pune

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Important information

  • Certificate
  • Pune
  • Duration:
    4 Months
  • When:

Many countries have started adopting the eCTD standard and are accepting eCTD submission. EMEA has started accepting eCTD Submission for all centralized procedure from 1st January 2010 as a step to mandate eCTD submission, paper submission for centralized procedure are no longer accepted.
The Course guides through various aspects of eCTD giving a complete understanding of what eCTD is and how companies can move from paper base to eCTD. The Program focuses on European and US eCTD Submission and help participants compile and submits and eCTD application. The Course is designed for students and Pharma professionals who have no or little knowledge in regards to eCTD and its submission.

Important information

Where and when

Starts Location Timetable
Prestige Classic BLD - Dwing Off no G4 & 5, CHinchwad station Chinchwad Pune, 411019, Maharashtra, India
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Frequent Asked Questions

· What are the objectives of this course?

4 Months Distance learning Program.

What you'll learn on the course

QC/QA Managers & Staff
Documentation Department
Regulatory Affairs Department - Responsible for CTD /DMF Preparation & Submission
Research Chemist
Quality Control Chemist

Teachers and trainers (1)

Global Institute of Regulatory Affairs
Global Institute of Regulatory Affairs
Drug Regulatory Affairs

Course programme

  • Introduction & Overview of CTD
  • CTD Fundamentals ( Module 1 - 5)
  • eCTD Fundamentals & Details
  • Best Practice in Preparing eCTD
  • Submission using eCTD Format
  • Life Cycle Management for eCTD
  • eCTD Software for Compilation & Validation
  • Key Point for Successful eCTD Submission
  • 2 Days hands on TRAINING on eCTD Software

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