Recently, specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials and the Directorate for Audit of Laboratory and Clinical Practices (GLP, GCP) held corporate training on clinical trials in Ukraine in accordance with the principles of Good Clinical Practice (GCP).
This time the listeners were employees of the Medical Research Center ARENSIA Exploratory Medicine. The purpose is to provide knowledge that will improve the quality of clinical trials of medicinal products, optimize the process of preparing documents, and familiarize attendees with the latest changes in the regulatory legal acts on clinical trials.
The Deputy Director for Clinical Affairs of the Center, Lobas M.V., gave the opening address to those present. He introduced the program of the event, its goals and objectives, and dwelt separately on the disclosure of the concept of “Good Clinical Practice (GCP)” and the place of the Center in this process.
During the seminar, which lasted almost 8 hours, the Center’s leading specialists covered a wide range of issues related to:
- regulatory framework for conducting clinical trials (CTs) of medicinal products (MPs) in Ukraine;
- basic principles of Good Clinical Practice (GCP);
- responsibilities of investigators and sponsors;
- documents accompanying clinical trials of medicinal products;
- ethical aspects of conducting clinical trials of medicinal products;
- clinical audit of clinical trials of medicinal products.
Separately, they dwelt on typical comments raised during the expert evaluation of clinical trial materials for medicinal products, the specifics of early-phase trial protocols, and interaction with DNTs/MoH/LEK. A block was also devoted to answers to participants’ questions.
The event speakers were:
- Taisa Herasymchuk – Director of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials;
- Lesia Yankova – Head of the Clinical Trials Clinical Audit Division of the Laboratory and Clinical Practices Audit Department (GLP, GCP);
- Tetiana Dmytrakova, expert of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials;
- Olha Silantieva, Head of the Division of Preliminary Expert Evaluation of Preclinical and Clinical Trial Materials of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials;
- Serhii Rasputniak, Head of the Laboratory and Clinical Practices Audit Department (GLP, GCP);
- Yana Maltseva, expert of the Clinical Trials Clinical Audit Division of the Laboratory and Clinical Practices Audit Department (GLP, GCP);
- Olha Smoliar, Head of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials.
We remind you that the Center, in accordance with its statutory powers, regularly holds scheduled seminars on the conduct of clinical trials in Ukraine in accordance with the principles of Good Clinical Practice (GCP) for applicants, developers of medicinal products, investigators, and all interested parties.
This scientific seminar is already the thirteenth this year in a series of comprehensive trainings on implementing GCP principles in Ukraine. The trainings are held in the form of presentations combined with discussion of questions that participants may have had during the training.
We thank our partners for their active participation in the seminar!
