In order to ensure openness and transparency of operation, the State Expert Center (hereinafter – the Center) has developed the “Visualization” system for applicants for clinical trials of medicinal products.
This system enables applicants/applicants' representatives to track online the progress through the stages of expert evaluation of the Applications for a clinical trial of a medicinal product/applications for a substantial amendment (hereinafter – Applications) they have submitted and the accompanying materials.
To obtain access to the “Visualization” system, it is necessary to submit a letter-appeal addressed to the Director of the Center and an authorization issued by the sponsor to represent its interests at the Center (if necessary). Samples of how to prepare these documents are available on the official website of the Center in the section “Visualization.”
The document “Letter of Appeal” is currently unavailable.
Please note that to obtain access to the “Visualization” system, the applicant’s name must be identical in the contract between the applicant and the Center for the conduct of expert evaluation, the Application, and the cover letter to the Center.
Suggestions and comments regarding the operation of the “Visualization” system should be sent to the e-mail address eias@dec.gov.ua.
