Compliance with GCP principles and improving the quality of clinical trials – an online seminar for researchers, developers of medicinal products and members of local ethics committees was held at the Center.
The training was devoted to the regulation of clinical trials in Ukraine, taking into account the principles of Good Clinical Practice (GCP).
The aim is to provide knowledge that will improve the quality of clinical trials of medicinal products in accordance with international standards, optimize the document preparation process, and familiarize attendees with the latest regulatory changes in the field of clinical trials.
The event was opened by the Head of the Agency for Methodological and Scientific and Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor Oleksandr Gudzenko. He familiarized the participants with the seminar program, goals, and objectives, introduced the speakers, and dwelt on the concept of “Good Clinical Practice (GCP)” and the role of the Center in this area.
In his report, he emphasized that the Center stands for supporting and increasing the number of high-quality clinical trials conducted in compliance with GCP principles.
The development of clinical trials in Ukraine enables patients to receive free treatment with new medicinal products, doctors to become familiar with new technologies for treating diseases, and the country to register and use products with proven efficacy and safety.
In covering the topic of the seminar, the Center's specialists and experts addressed the following issues for the audience:
- regulatory and legal aspects of conducting clinical trials in accordance with ICH GCP;
- ethical aspects of conducting clinical trials;
- specifics of maintaining documents that accompany clinical trials;
- compliance with the duties of the investigator and sponsor of clinical trials;
- specifics of preparing and conducting clinical audits of clinical trials of medicinal products.
In addition to the main aspects of organization and control, the issue of conducting clinical trials under martial law was also discussed.
Presentations were given by:
- Taisa Herasymchuk – Director of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials;
- Olha Smoliar – Head of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials;
- Hanna Anichkina – expert of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials;
- Yurii Shemetylo – Head of the Division for Coordination of Local Ethics Committees;
- Lesia Yankova – Head of the Division of Clinical Audit of Clinical Trials;
- Yana Maltseva – expert of the Division of Clinical Audit of Clinical Trials.
At the end, together with the participants, the lecturers worked through the answers to the questions and provided professional comments and clarifications.
In total, about 70 participants joined the training. All of them will receive certificates of course completion.
Concluding the seminar, Oleksandr Hudzenko drew attention to the importance of feedback and encouraged participants to share their comments and suggestions on the content and quality of the seminar. Those wishing to may send completed questionnaires to the Agency's address amsw@dec.gov.ua
We remind you that the Center, in accordance with its statutory powers, regularly conducts seminars on compliance with the principles of Good Clinical Practice (GCP) during the conduct of clinical trials.
You can register for the next seminar on this topic via the link https://www.dec.gov.ua/…/navchalni-seminari…/
