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.

#COURSE DETAILS:

*Program Name – Certificate
Course in eCTD Submissions (Distance Learning)

*Duration – 01 Months

*Mode – e-Learning

*Fees – Rs 20,600/-

# COURSE HIGHLIGHTS:

*2 Session Hands-on Experience of e-CTD Software (Online/Offline)

* Completely Online (From Admission to Examination)

*Self Paced program designed for Working professionals and students
pursuing higher studies

* e-Learning materials (audio video lectures,MCQ tests, Assignment)

* Online Interaction option with the Faculty

* Industry Accepted Course Curriculum

*Certificate on Course Completion

* Online Examination (MCQ Type)

* 100 % Placement Assistance & Career Guidance

# TOPICS COVERED:

1.Introduction to eCTD

2. eCTD Around the World

3. eCTD & its Components – Folder Structure

4. eCTD & its Components – XML-Meta Data-DTD-Style Sheet

5. eCTD & its Components – Folder/ File Naming & Structure Variation

6. Creating eCTD Compatible Files – PDF

7. Creating eCTD Compatible Files – Scanned Documents – Hyperlink-Bookmarks

8. Creating eCTD Compatible Files – PDF Properties-Electronic Signature-SVG File

9.How to Check your file before Submission ?

10.eCTD Life cycle Management

**eCTD- Assignments & Final Assessment with MCQ

FOR DETAILED INFORMATION:

Call us at:
9595750750 / 020 46704472

Mail us at: info@regulatoryinstitute.com