The Center held the first seminar this year on regulation of conducting clinical trials of medicinal products in accordance with the Good Clinical Practice standard GCP ICH E6(R2).
The event was held by the Agency for Methodological and Scientific-Practical Work. The course was taught by specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials and the Audit Division of the Center.
81 participants took part in the webinar – representatives of healthcare institutions of various forms of ownership and contract research organizations involved in conducting clinical trials.
The attendees were presented with issues that most fully describe all aspects of conducting a clinical trial in Ukraine, in order to ensure its completeness and quality, as well as the rights, safety, and well-being of trial subjects:
- Regulatory and legal framework for conducting clinical trials in accordance with ICH GCP
- Activities of ethics committees
- Ensuring patient rights and the procedure for obtaining informed consent from the trial subject
- CT sites and the research team – regulatory requirements for them
- Investigational medicinal product in clinical trials
- Prospects for conducting clinical trials of advanced therapy medicinal products in Ukraine
- Proper maintenance of the documentation accompanying the clinical trial
- Investigator's responsibilities
- Sponsor's responsibilities. Monitoring. Audit
- Clinical audit of clinical trials.
The knowledge gained is important for the proper organization of clinical trials, ensuring the quality of studies, the reliability of results, and patient safety. It is also valuable in the context of the emergence of a new professional standard in healthcare – clinical research professional.
Head of the Center's Agency, Doctor of Pharmaceutical Sciences, Professor, Honored Health Care Worker Oleksandr Hudzenko reminded that GCP training is conducted by the Center on a regular basis. The Program of External Training Events for 2025 provides for 10 GCP seminars, as well as 2 webinars with members of ethics committees, 2 thematic seminars on clinical audit and preclinical studies, and 2 GLP training sessions.
