The Center held another online seminar “Good Clinical Practice (GCP). Regulatory and legal framework for clinical trials in Ukraine” (GCP. Clinical trials regulation). The organizer of the event was the Agency for Methodological and Scientific-Practical Work of the Center.
More than 80 participants took part in the event – researchers and representatives of ethics committees at healthcare facilities of various forms of ownership involved in conducting clinical trials in Ukraine.
In addition to the main aspects of organizing and monitoring clinical trials, the seminar addressed current issues of conducting clinical trials under martial law. The main goal is, despite the war, to create and ensure in Ukraine attractive conditions for conducting clinical trials in compliance with GCP requirements and international ethical principles on the protection of the rights, safety, and well-being of trial subjects.
A welcoming address to the participants was given by Andrii Halstian, leading specialist of the Agency. He reminded them that the event is held as part of the Center's training program, and presented the agenda and speakers.
He stressed that the Center officially holds the status of a provider of continuous professional development (CPD) for employees in the fields of “Medicine” and “Pharmacy” under the Ministry of Health of Ukraine, and encouraged participants to join other training courses as well.
During the workshop, the Center's speakers – specialists of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials and the Office for Audit of Laboratory and Clinical Practices (GLP, GCP) – covered the following topics:
- Regulatory framework for conducting clinical trials in Ukraine, basic principles of Good Clinical Practice (GCP ICH) (speaker: Taisa Herasymchuk, Director of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials);
- Investigator's responsibilities (speaker: Head of the Clinical Trials Clinical Audit Department Lesia Yankova);
- Activities of ethics committees at healthcare facilities where clinical trials of medicinal products are conducted (speaker: Yurii Shemetyllo, Head of the Division for Coordination of Local Ethics Committees and Monitoring of Adverse Reactions);
- The procedure for obtaining informed consent of a trial subject (speaker: Olha Smoliar, Head of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials);
- Documents accompanying a clinical trial (speaker: Hanna Anichkina, expert of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials);
- Sponsor's responsibilities. Monitoring. Audit (speaker: expert of the Clinical Trials Clinical Audit Department Nina Tsyntsadze);
- Clinical audit of a clinical trial (speaker: Lesia Yankova, Head of the Clinical Trials Clinical Audit Department).
At the end of the event, Andrii Halstian congratulated those present on gaining new knowledge and informed them about the procedure for obtaining certificates. He drew attention to the importance of participants evaluating the content of the seminar in order to further improve its quality and effectiveness.
The next seminar on this topic will be held once a group of attendees has been formed. Details of participation and the application form are on the Center's website at this link. Enrollment is open!
We also remind you that on 29 June 2023 a large-scale industry event in the field of clinical trials will take place – the pharmaceutical forum “Clinical Trials in Ukraine. European Integration.” We invite you to join! Details, the event program and registration at the link
