Invited to participate: applicants, regulatory affairs specialists, representatives of pharmaceutical companies, and other interested parties.
Purpose of the seminar: to present and discuss the issues of the mandatory introduction in Ukraine of submission of registration dossier materials in the electronic Common Technical Document (eCTD) format during state registration of medicinal products.
Programme:
- Key aspects of submitting the Application.
- Support of registration materials: discussion of typical errors and ways to avoid them.
- Concept of forming and submitting registration dossier materials in eCTD format
- Current issues of submitting and obtaining registration materials and documents.
Organizers and speakers of the seminar: Agency for Methodological and Scientific-Practical Work in cooperation with specialists of the Department of Expert Evaluation of Registration Materials and the Department of Coordination of Expert Materials of the Center.
Format of participation: offline.
Certificate: After participating in the seminar, each participant will receive a certificate.
Registration
To participate, you must fill out an application and send it electronically in doc / docx format to the address of the Agency for Methodological and Scientific-Practical Work amsw@dec.gov.ua
Contact person
Svitlana Borodai, leading specialist of the Agency for Methodological and Scientific-Practical Work, tel.: +38 (044) 202-17-00 (2251), e-mail: borodai@dec.gov.ua
Additional information
The seminar will be held in pursuance of the Plan of external training events of the State Expert Center of the Ministry of Health of Ukraine for 2026, developed with the aim of raising the level of professional awareness, developing key competencies, disseminating best practices and supporting sustainable development in the field of healthcare, taking into account changes in the system, current needs, challenges and expectations of external stakeholders. The Center's training events are aimed at disseminating current knowledge and supporting effective interaction in the pharmaceutical and medical sectors in accordance with the Center's statutory tasks. The Plan provides for a series of training events in various formats — from practical seminars to specialized thematic webinars, in online and offline formats.
Contacts
We will be glad for your participation and feedback!
