Webinar

Global outlook for eCTD 4.0 adoption: Successes and challenges

Although the main International Council for Harmonisation (ICH) eCTD v4.0 standard has been available since 2015, implementation at regulatory agencies to date has been slow. Recently, however, the pace has quickened. Watch an insightful webinar on demand for an informative update from our eCTD expert Karl-Heinz Loebel on the accelerating adoption of eCTD 4.0, and key challenges still facing industry. In addition, he will provide pragmatic guidance for companies seeking to implement the updated standard and provide an outlook on future extensions to the standard.

Key learnings

  • Findings and lessons learned from the second phase of the EMA’s eCTD 4.0 EU technical pilot, and expectations for the coming months.
  • Current state of eCTD 4.0 submissions to the FDA, exploring the synergies between US and EU applications.
  • Important considerations for companies looking to adopt eCTD 4.0, including how it fits into your overall workflow of creating submissions, handling of the controlled vocabularies, keywords, and other eCTD 4.0 features.
  • How forward compatibility works with the lifecycle of an existing eCTD dossier.
  • Potential applications of eCTD 4.0 capabilities to the submission of structured product data in the future.
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