Ukraine is actively resuming clinical trials of medicinal products and expanding the geography of research sites.
Therefore, constant deepening and updating of knowledge about the regulatory requirements for conducting them is very important for those who organize and conduct them.
On April 26, the Center held its regular monthly seminar “Good Clinical Practice (GCP). Regulatory framework for conducting clinical trials.” About 60 participants took part in the event – representatives of manufacturers, research organizations, local ethics committees, advisory and expert groups, and other stakeholders.
GCP covers all processes of a clinical trial, defines requirements for reporting and documentation, and ensures that the study is of high quality and scientifically and ethically sound.
GCP training was conducted by specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials of Medicinal Products and the Audit Directorate. Speakers included: Taisa Herasymchuk, Yurii Shemetyllo, Olha Smoliar, Tetiana Dmytrakova, Lesia Yankova, Nina Tsyntsadze, Serhii Rasputniak.
In their presentations, they covered:
- regulatory, legal, and ethical aspects of conducting clinical trials in accordance with the requirements of current and new legislation on medicinal products and international and ethical standards of Good Clinical Practice (GCP);
- specifics of the work of ethics committees at healthcare institutions involved in conducting research;
- procedure for maintaining documentation at different stages of the clinical study life cycle;
- duties of the investigator, sponsor;
- the procedure for conducting clinical audits of clinical trials of medicinal products.
Special attention was paid to the specifics of conducting clinical trials under martial law; answers to questions were provided.
We remind you that the Center holds seminars on GCP issues on a regular basis. In the first quarter of this year alone, 130 participants joined the training and received certificates.
The next GCP seminar will take place in a month, 24 May 2024.
You can register using the contacts of the Agency for Methodological and Scientific-Practical Work of the Center: amsw@dec.gov.ua, tel. 202-17-00 (2251).
For your information, the Center previously published an Information Note on the status of clinical trials of medicinal products in Ukraine for Q1 2024. http://surl.li/sxnqo
