The Center held this year's final seminar on GCP issues. During this and previous trainings, the Center's specialists examined in detail the specifics of conducting clinical trials in Ukraine in accordance with the requirements of GCP – the international standard that guarantees the quality of a clinical study, its scientific and ethical soundness, and the reliability and accuracy of the results obtained.
During the lectures, trainees became familiar in detail with:
- The regulatory framework for conducting clinical trials in accordance with ICH GCP
- Specifics of the activities of ethics committees
- By the procedure for obtaining the informed consent of the trial subject
- Requirements for maintaining the documentation accompanying a clinical trial
- Responsibilities of investigators and sponsors
- Specifics of preparing for clinical audits of clinical trials.
Special attention was paid to current issues of conducting clinical trials in wartime and ensuring the rights, safety and well-being of trial subjects.
This year, experts of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials and the Laboratory and Clinical Practice Audit Department (GCP, GLP) of the Center shared their experience and knowledge with seminar participants: Taisa Herasymchuk, Olha Smoliar, Yurii Shemetyllo, Daria Andrieieva, Tetiana Dmytrakova, Hanna Anichkina, Lesia Yankova, Nina Tsyntsadze, Serhii Rasputniak.
The training was organized by the Agency for Methodological and Scientific-Practical Work of the Center under the supervision of Doctor of Pharmaceutical Sciences, Professor, Honored Healthcare Worker of Ukraine Oleksandr Hudzenko.
In total during 2023, the Center held 9 seminars on Good Clinical Practice (GCP) (including 1 off-site seminar in Lviv), which were attended by about 500 participants in total, who received certificates.
The Center will continue to conduct the course on a regular basis next year as well. Our goal is to implement the best global and European practices in the field of clinical research in Ukraine, to develop the range of clinical trials, and to provide constant informational and methodological support to manufacturers, investigators, healthcare facilities and contract research organizations, members of local ethics committees, and all those involved in the processes of conducting clinical trials.
Please note that next year the topic of the quality of clinical trials will also be included in the professional development (PD) seminars – the first one is already planned for January 2024; details for registration are available at the link https://bpr.dec.gov.ua/events/osoblyvosti-provedennya-klinichnyh-vyprobuvan-likarskyh-zasobiv-v-ukrayini/
