eCTD Training in Ukraine, Online. Theoretical and Practical Parts, Q&A Session

Effective January 1, 2027, the main provisions of Ukraine’s new Law “On Medicines” come into force, making the transition to digital mandatory for all regulatory procedures: new registration, re-registration, indefinite registration renewal, and variations.

This not only alters the dossier submission format and interaction with the regulatory authority during assessment, but also introduces new regulatory requirements, demanding updated knowledge and skills from the regulatory affairs department. eCTD is becoming more than just a submission format—it is the single digital environment for maintaining the lifecycle of every drug product registration.

Transitioning to eCTD is particularly relevant for the day-to-day operations of regulatory departments in current Ukrainian conditions. The electronic format reduces routine work, eliminates costs associated with paper dossiers and delivery, and turns remote submission into standard practice.

We invite you to a webinar dedicated to the implementation of eCTD in Ukraine. The program features theoretical and practical sections, an analysis of the most common errors, and a Q&A session.

• Date: November 12, 2026
• Time: 11:00 AM (Kyiv time)
• Duration: Approximately 2.5 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.