Published June 1, 2021 | Version v1
Lesson Open

EFSA: IUCLID Training for regulators


The course covers the following content:
◼ Overview of ECHA Cloud Services; including using the VPN connection to access the Agency IUCLID

◼ Searching for dossiers and the dossier dashboard

◼ The key concepts of an IUCLID dossier:

  • Dossier header,
  • Mixture/Product dataset,
  • Active substance dataset,
  • Other substance assessment dataset,
  • Other mixture dataset.

◼ The purpose of IUCLID entities:

  • Reference substance,
  • Contact,
  • Sites,
  • Reference substance,
  • Test Material
  • Literature reference. For literature reference the use of ‘Other study identifier(s)’ to the Notification of Studies database and the separation of original and sanitised attachments is explained.

◼ The difference between Endpoint study records, Endpoint summaries, Flexible records and Flexible summaries is explained

◼ Using validation assistant to check for dossier completeness and using annotation to record missing information

◼ Using report generator – examples of a confidentiality report and a notification of studies report

◼ Using the Compare tool to find differences when a new version of a dossier has been received

◼ How to get more information and resolve issues

In order to view the course either open the PDF file or use the .zip file to view its web version by following the below steps:

  1. save on your PC the .zip folder
  2. extract it locally
  3. under the Content folder open the "index.html" file





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