Compliance with GCP requirements during clinical trials of medicinal products – a certified online seminar for manufacturers, investigators, representatives of CROs, managers, and members of local ethics committees was held at the Center.
The basis of the training is a review of the regulatory requirements for conducting clinical trials in Ukraine, which are based on compliance with the mandatory norms and principles of Good Clinical Practice (GCP) – the international standard for clinical trials of medicinal products.
The international ethical and scientific standard covers all processes of a clinical trial, namely: planning, conduct, performance, monitoring, audit, and documentation, as well as the processing and presentation of their results. GCP is a guarantee of the reliability and accuracy of the data obtained and the results presented, the protection of the rights and health of trial subjects, and the maintenance of confidentiality with regard to them. The standard ensures that the trial is scientifically and ethically sound.
The event took place under the leadership of the Agency for Methodological and Scientific-Practical Work of the Center. The seminar was opened by the head of the Agency, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko. Specialists of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials and the Laboratory and Clinical Practice Audit Division (GCP, GLP) of the Center gave reports and presentations: Taisa Herasymchuk, Yurii Shemetyllo, Olha Smoliar, Tetiana Dmytrakova, Lesia Yankova, Nina Tsyntsadze and Serhii Rasputniak.
The training covered:
- regulatory and legal aspects of conducting clinical trials in accordance with GCP requirements
- ethical aspects of clinical studies
- specifics of the activities of ethics committees at healthcare institutions involved in conducting clinical trials
- maintaining documentation at different stages of the clinical trial life cycle
- investigator's responsibilities, sponsor's responsibilities
- oversight by the regulator over the conduct of clinical studies. Clinical audit of a clinical trial
In addition to issues of organization and control, the speakers also addressed the specifics of conducting clinical trials under martial law. They provided expert recommendations and explanations in response to participants’ questions.
A total of 33 trainees took part in the training.
In conclusion, the speakers reminded that the Center uses every form of communication with clinical trial stakeholders, stays in constant offline/online contact, regularly provides all necessary methodological recommendations, conducts free webinars for members of local ethics committees, and provides free consultations. They called for cooperation and exchange of information on all issues of clinical trial development in Ukraine.
As a reminder, the Center holds seminars on compliance with Good Clinical Practice (GCP) on a regular basis, which allows participants to stay informed of the latest changes and updates in international and national legislation on the organization and conduct of clinical trials and to receive up-to-date information from the Center’s experts. You can register for the next one using the contacts of the Agency: amsw@dec.gov.ua, tel. 202-17-00 (2251).
