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The upcoming introduction of eCTD signifies an important shift for Ukrainian pharmaceutical entities. Together with Medicines for Europe, we are happy to host a webinar where we navigate this uncharted territory together. From understanding the technical aspects of eCTD to practical tips for submission preparation, participants will gain the knowledge and insights necessary to streamline the drug registration process and enhance regulatory compliance.

We are honored to welcome a distinguished guest from a national authority who will support the Ukrainian industry in navigating the eCTD submission process.

We are also pleased to present to you the general information partner of the event - "PHARMACY Weekly", a Ukrainian specialized magazine for healthcare professionals

Organizational Details:

Date: 16 May 2024

Time: 10:00 – 13:00 EEST  (09:00 – 12:00 CEST) - including several breaks that leave time for Questions & Answers!

Language: Please note that the webinar will be mainly held in English. However, our valuable Ukrainian partner, DataMind Global, supports us in the translation of slides as well as in the translation of questions and answers.

The webinar is completely free. Please use the form on this page to register.


  1. Introduction
  2. Current regulatory status in the Ukraine
  3. Brief History of eCTD
  4. eCTD on a global scale
  5. eCTD Basics, Technical files, and Workflow
  6. eCTD - Pre-Requisites
  7. Lifecycle Management
  8. eCTD Validation
  9. Details of Ukraine Regional M1 eCTD
  10. Electronic submissions comparison: ICH eCTD and EAEU
  11. Transitioning to eCTD - how to prepare your documents and data
  12. Software Demo: creating and validating an eCTD sequence


Your speaker:

Michael Faust, Business Consultant at the Regulatory Competence Center, will take you on an informative journey towards eCTD - from the beginning to the Ukrainian specifications that have been introduced lately. Starting with the basics, he will explain the different steps of a successful submission and show you how to prepare your data and documents.

Michael is not only passionate about this topic, but he is also an experienced and patient trainer who knows how to deliver complex information in an understandable and interesting way. Use this opportunity to get answers to all your questions!


Good To Know:

After the webinar, every participant will receive a certificate to confirm attendance.

Not sure if you can make it on time? Register anyway and receive the recording!