On 10 June 2026, the Cabinet of Ministers of Ukraine approved: the Technical regulation on medical devices (Resolution of the Cabinet of Ministers of Ukraine No. 759), developed based on Regulation (EU) 2017/745 (MDR); the Technical regulation on in vitro diagnostic medical devices (Resolution of the Cabinet of Ministers of Ukraine No. 758), developed based […]
eCTD Training in Ukraine, Online. Theoretical and Practical Parts, Q&A Session
October 14, 2026, from 11:00 AM to 2:00 PM, Online.
Duration: approx. 2.5 hours, plus 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.
Participation is free upon prior registration.
We reserve the right to refuse participation without explanation.