Regulatory requirements for conducting clinical trials of medicinal products in Ukraine, compliance with GCP requirements – Center specialists held a monthly webinar for stakeholders.
37 participants took part, including medicinal product manufacturers, researchers, local ethics committees, and others involved in conducting clinical trials in Ukraine.
The purpose of the training is to deepen awareness of the regulatory requirements and ethical principles of quality and safety in conducting clinical trials of medicinal products in Ukraine, taking into account the requirements of current and new legislation on medicinal products and the international and ethical standards of good clinical practice ICH GCP.
The training was organized by the Agency for Methodological and Scientific-Practical Work of the Center. The speakers were specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials of Medicinal Products and the Audit Department of the Center: Taisa Herasymchuk, Yurii Shemetyllo, Tetiana Dmytrakova, Nina Tsyntsadze, Serhii Rasputniak.
In their presentations, they covered key aspects of the organization and conduct of clinical trials in Ukraine, including taking into account the specifics of martial law:
- regulatory, legal and ethical principles of conducting clinical studies in accordance with the requirements of current and new legislation on medicinal products, international and ethical standards of Good Clinical Practice (GCP)
- 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
- compliance with the procedure for obtaining the subject’s informed consent
- investigator responsibilities
- sponsor responsibilities
- the procedure for conducting clinical audits of clinical trials of medicinal products.
“Despite the challenges of war, the Center is committed to developing the clinical trials sector and attracting international sponsors (manufacturers) to Ukraine. To this end, regulatory provisions are being harmonized in line with the best European and global practices, coordination and support are being provided to all parties involved in clinical trials, and proper control and audit are being carried out at all stages of conducting clinical trials,” emphasized Taisa Herasymchuk, Director of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials of the Center.
“Systematic GCP seminars are the best opportunity to deepen and update the most current knowledge about regulatory requirements and the processes of conducting clinical trials in Ukraine and worldwide. The seminars are certified and are held by the Center on a regular basis. In the first half of this year, the Center held 6 such seminars, including 1 off-site seminar in the city of Kropyvnytskyi. In total, about 350 participants took part in them,” summarized Valeriia Yefremova, representative of the Agency. The next seminar is scheduled for 13 September 2024, after a short summer break.
