EFSA: IUCLID Training for applicants (sessions 18/3 & 22/3)

This presentation was performed on 18/3 & 22/3 (available in PDF and .mp4) and 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

Finally, the respective Q&A sessions have been attached in .mp4 for ease of reference.