eCTD Submission Certification Program - Part Time/Distance learning

Certificate

Online

Rs 20001-30000

Description

  • Type

    Certificate

  • Methodology

    Online

  • Duration

    4 Months

  • Start date

    Different dates available

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.

Facilities

Location

Start date

Online

Start date

Different dates availableEnrolment now open

About this course

3 Months Distance learning Program.

Life Science Graduates, Regulatory Affairs freshers and professional

Video Lecture + Practical Exposure

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Reviews

Subjects

  • QC/QA Managers & Staff
  • Documentation Department
  • Research Chemist
  • Quality Control Chemist
  • Distance Learning
  • Regulation
  • Pharmacy
  • Marketing Authorization
  • Regulatory Affairs Professionals
  • Regulatory Affairs Associates

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

eCTD Submission Certification Program - Part Time/Distance learning

Rs 20001-30000