Another free online seminar devoted to current issues of conducting clinical trials of medicinal products in Ukraine, taking into account the principles of Good Clinical Practice (GCP), was held at the Center. In total, 60 participants took part.
Continuous deepening of knowledge of the regulatory requirements for conducting clinical trials of medicinal products is extremely important. The international GCP standard covers all processes of a clinical study of a medicinal product, defines requirements for reporting and documentation, and guarantees that the study is of high quality and scientifically and ethically sound.
Specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials of Medicinal Products and of the Audit Directorate delivered reports and presentations at the seminar: Taisa Herasymchuk, Yurii Shemetyllo, Olha Smoliar, Tetiana Dmytrakova, Lesia Yankova, Nina Tsyntsadze, Serhii Rasputniak. The event was led by the Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko.
The following issues were covered during the training:
- regulatory, legal and ethical aspects of conducting clinical studies in accordance with GCP requirements
- specifics of the activities of ethics committees at healthcare institutions involved in conducting clinical trials
- procedure for maintaining documentation at different stages of the clinical study life cycle
- investigator's responsibilities, sponsor's responsibilities
- regulatory oversight of the conduct of clinical trials. Clinical audit of a clinical trial.
During the discussion, our specialists answered the audience’s questions, provided consultations on the specifics of conducting clinical trials under martial law, and reminded participants of the contact details for interaction with the Center.
We remind you that GCP seminars are certified and are held by the Center on a regular basis.
The next one will take place in just a month, on 22 March 2024. You can register using the Agency’s contacts: amsw@dec.gov.ua, tel. 202-17-00 (2251)
