Ensuring the quality and safety of clinical trials in view of GCP requirements – the Center held another online seminar for stakeholders. The training was organized by the Agency for Methodological and Scientific-Practical Work of the Center.
Representatives of medicinal product manufacturers, researchers, local ethics committees and others involved in conducting clinical trials joined the training – 63 participants in total.
The attendees’ main focus was on the regulatory requirements for conducting clinical trials, taking into account the international standard of good clinical practice (GCP), which guarantees the quality of a clinical trial, its scientific and ethical soundness, and the reliability and accuracy of the results obtained.
Presentations were given by specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials of Medicinal Products and of the Audit Division of the Center: Taisa Herasymchuk, Yurii Shemetyllo, Tetiana Dmytrakova, Lesia Yankova, Nina Tsyntsadze, Serhii Rasputniak.
In their presentations, they covered:
- 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
- investigator responsibilities
- sponsor responsibilities
- procedure for conducting clinical audits of clinical trials of medicinal products: how to prepare.
Special attention was paid to the specifics of conducting clinical trials under martial law, and answers to questions were provided.
“Continuous deepening and updating of knowledge about regulatory requirements for conducting clinical trials is very important for those who organize and conduct them,” emphasized Taisa Herasymchuk, Director of the EMDKV Department of the Center. “Systematic monthly GCP seminars, continuous informational and methodological support, ensuring communications, and the Center’s close cooperation with all stakeholders are the key to preserving the potential, high-quality conduct, and development of clinical trials in Ukraine.”
Taking the opportunity, she also invited those interested to take part in the Center’s CPD seminar to be held on June 5, devoted to the organization of a clinical trial site in a healthcare facility.
Details at the link http://surl.li/txdbp
We remind you that the next GCP seminar will take place in a month, on June 21, 2024. You can register using the contacts of the organizer – the Agency for Methodological and Scientific-Practical Work of the Center, tel. 202-17-00 (2251), amwc@dec.gov.ua
