The event was organized on the initiative and with the support of the Agency for Methodological and Scientific-Practical Work of the Center as part of professional development activities for healthcare workers.
“The full-scale military aggression of the russian federation has significantly affected the planning and conduct of clinical trials of medicinal products in Ukraine. Therefore, the State Expert Center supports the clinical trials sector in order to increase the number of studies in our country that are conducted in compliance with good clinical practice (GSP),” – emphasized the representative of the Agency, Doctor of Chemical Sciences, Professor Andrii Halstian, at the opening of the event.
Experts of the State Expert Center – Serhii Rasputniak, Deputy Head of the Audit Department, and Lesia Yankova, Head of the Division of Clinical Audit of Clinical Trials, covered the key aspects of how to join a team of researchers: from setting up a trial site to selecting participants and ensuring the quality of the study itself.
Typical remarks regarding the organization of trial sites, which have emerged from the results of clinical audits conducted by the Center, were considered.
The seminar program included the following practical topics:
- What a trial site is and the criteria it must meet.
- Which healthcare facilities (HCFs) may be involved in conducting clinical trials?
- Regulatory and legal requirements for private and municipal healthcare facilities in which trials are planned to be conducted.
- Requirements for personnel involved in clinical trials and distribution of authority.
- Ethics Committee – purpose of establishment, tasks, and documents required for its work.
Following the seminar, its participants took a test, received a certificate, and +10 points within the framework of professional development.
You can learn more about professional development activities on the page of the Agency for Methodological and Scientific-Practical Work of the Center https://bpr.dec.gov.ua/
Also follow the announcements and events of the State Expert Center to stay informed about our activities https://www.dec.gov.ua/announcement/
