Lesson Open Access

EFSA: IUCLID Training for applicants

European Food Safety Authority

This course covers the following contents:
◼ Overview of ECHA Cloud Services including registering for and accessing the full IUCLID Cloud service and the ECHA submission portal:

  • The use of Foreign entity is explained for applicants using regulatory affairs consultants or preparing a joint submission.
  • The purpose of the Legal Entity is described and the importance of maintaining legal entities for companies submitting under different EU legislations emphasised

◼ 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.

◼ Create dossier. The key steps are described:

  • + New mixture / product
  • Selecting ‘Working context’ and switching ‘Working context’ in cases where datasets are already available
  • Completing “Mixture Composition” and “Metabolites Information” documents (Reference substance with active substance function, Reference substance, only substance)
  • Accessing the datasets in the TOC.

◼ The difference between Endpoint study records, Endpoint summaries, Flexible records and Flexible summaries is explained.
◼ Complete a dossier:

  • Add new endpoint study record, include a Literature reference and Test material, set confidentiality flags, option to complete data waiving
  • Add a new endpoint summary, link to an endpoint study record
  • Add a Flexible record
  • Use of “Copy data from …” feature

◼ Use of IUCLID features:

  • Create dossier and completion of the dossier header
  • Validation assistant
  • Dissemination preview

◼ Submit a dossier:

  • Export dossier
  • Upload/submission within the submission portal

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

 

EU; PDF; data.admin@efsa.europa.eu
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