A webinar with the awarding of professional development points on the organization of clinical trial sites at healthcare institutions was held at the Center.
The event brought together investigator physicians, heads of healthcare facilities, members of ethics committees and specialists who are involved in conducting clinical studies in Ukraine or are interested in joining.
High-quality organization of clinical trial processes, proper training of research teams and members of ethics committees are of great importance for ensuring the rights, safety, and well-being of study participants, as well as the reliability of the results obtained.
As the authorized body of the Ministry of Health of Ukraine, the Center provides training participants with the most up-to-date clarifications in the field of clinical trials, based on the requirements of national legislation as well as the principles and provisions of the international standard of good clinical practice ICH GCP.
The seminar addressed practical issues:
- organization of the trial site;
- organization of clinical trials in healthcare facilities of various profiles and forms of ownership;
- forming a research team;
- requirements for the activities of ethics committees;
- selection of study participants and quality control of processes;
- typical findings identified during clinical audits.
The speakers at the event were Serhii Rasputniak, Deputy Head of the Directorate for Audit of Clinical and Preclinical Studies and Pharmacovigilance Systems of the Center, and Nina Tsyntsadze, expert of the Division of Clinical Audit of Clinical and Preclinical Studies of the Center.
The knowledge gained was useful for deepening the professional competencies of the management and medical staff of hospitals and for developing the research potential of healthcare facilities. Participation in professional development seminars allows doctors not only to obtain up-to-date knowledge from leading experts of the Center but also to supplement their professional portfolio with continuous professional development points.
For your information, clinical trials are currently conducted in Ukraine at 185 healthcare institutions. Of these, 23 are state-owned, 96 are municipal non-profit enterprises, and 66 are private medical institutions. Expanding the network of clinical sites and ensuring their compliance with European standards is an important prerequisite for the further development and competitiveness of the industry.
