New course: Electronic Common Technical Document (eCTD)

Wed 22 May 2013 @ 11:04

Zenosis, the leading provider of specialized training solutions for the pharmaceutical industry has announced the release of a new e-course, Electronic Common Technical Document (eCTD).

This 2.5 hour module is an essential tool for regulatory affairs and compliance staff and specialists in data handling, knowledge management or documentation. Project managers and experienced drug development staff who contribute to regulatory submissions will also wish to familiarise themselves with its contents.

This module details the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission.

The eCTD module is an excellent reference and training tool and will assist anyone involved with electronic submissions in navigating these changing requirements.

Learning objectives:

  • Describe the structure, requirements and functionality of the eCTD.
  • Outline XML basics and the architecture of the eCTD.
  • Discuss Document Type Definitions (DTDs).
  • Explain how to build an eCTD.
  • Specify regional differences.
  • Discuss life cycle and change management.
  • List criteria that will make an electronic application technically valid.
  • Initiate electronic transfer to a regulatory authority.
  • Create, submit and maintain an eCTD dossier throughout the life of a drug product.