Invitation to the Training Event on eCTD – May 14, 2025

The Electronic Common Technical Document (eCTD) is an electronic format for registration dossiers, compliant with ICH requirements. Starting from August 18, 2025, in accordance with Clause 6 of Article 13 of the Law of Ukraine “On Medicinal Products” (2022 edition), the submission of dossiers in eCTD format will become mandatory.

By Order No. 691 of the Ministry of Health of Ukraine dated April 23, 2024, the specification for Module 1 in Ukraine and the validation criteria for verifying the eCTD electronic format have been approved. The State Expert Center of the Ministry of Health of Ukraine has updated the software of the Unified Information Automated System for working with eCTD (Applicant’s Portal, Pharma Decisions, Electronic Archive).

We invite you to a webinar dedicated to the implementation of eCTD in Ukraine.

• Date: May 14, 2025
• Time: 11:00 AM (Kyiv time)
• Duration: Approximately 1.5 hours, plus Q&A session
• Format: Online
• Language: Ukrainian 
• Participation: Free of charge, prior registration required 

Event program:

Theoretical Part: Features of Preparing a Registration Dossier in eCTD Format

• Implementation of eCTD and transition periods in the EU and Ukraine
• Differences between eCTD in the EU and Ukraine
• Registration procedures in Ukraine where eCTD is not applicable
• Requirements for transitioning to eCTD
• Specification of Module 1 UA eCTD
• UUID of the dossier and its entry into the registration form
• Electronic signatures
• Baseline submission and sequences
• Submission of dossiers through the Applicant’s Portal
• Response to regulatory comments and related sequences
• Submission and processing of variations

Practical Part: Demonstration of Electronic Dossier Preparation Using eCTD-RIMS

• Preparation of a registration dossier in eCTD format for new registration or baseline submission
• Directory (folder) structure for different types of applications
• File naming conventions and common errors
• Folder with working documents (CTD Module 3, package leaflet, labeling, RMP, and amendments) submitted outside the eCTD structure
• Signing documents with a Qualified Electronic Signature (QES)
• Dossier validation before submission
• Handling regulatory authority comments
• Creating new sequences and linking them to the main sequence
• Preparation of variations and re-registration
• Collaborative preparation of eCTD documents by different departments of a pharmaceutical company
• Conversion of paper-based dossiers into eCTD-compliant document files

Discussion and Q&A Session

Speakers: experts from IRIS Soft, a national software developer for eCTD:

• Daria Ferents – Technical Director at iRIS Soft, Head of Medical Information Systems Development
• Ninel Uskova – Head of eCTD-RIMS System Development
• Vita Shyshlakova – Business Analyst for eCTD at iRIS Soft

To register, please fill out the registration form.

Please note: We reserve the right to refuse participation without explanation.