The Center held the last seminar of 2024 on compliance with the international standard of Good Clinical Practice (GCP) in conducting clinical trials of medicinal products – in total, about 500 listeners completed the course and received certificates during the year.
Participants included representatives of contract research organizations, healthcare facilities, ethics committee members, manufacturers and researchers of medicinal products, and other interested parties. A series of presentations was delivered by specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials and the Audit Department of the Center.
As is traditional, the attendees were presented with the issues that most fully describe all aspects of conducting a clinical trial in Ukraine, with the aim of ensuring its completeness and quality, as well as the rights, safety, and well-being of trial subjects:
- Regulatory and legal framework for conducting clinical trials in accordance with ICH GCP
- Activities of ethics committees at healthcare facilities where clinical trials of medicinal products are conducted
- Proper maintenance of the documentation accompanying the clinical trial
- Ensuring patient rights and the procedure for obtaining informed consent from the trial subject
- CT sites and the research team – regulatory requirements for them
- Investigational medicinal product in clinical trials
- Investigator's responsibilities
- Sponsor duties, monitoring, and audit
- Clinical audit of clinical trials.
“The MoH and the Center continue the processes of implementing the best European and world regulatory practices on Ukraine’s path to European integration. The knowledge of GCP that we provide within the educational course helps everyone involved in the conduct of clinical trials in Ukraine to ensure their quality, to support the sustainable development of the sector in wartime conditions, to be attractive to international sponsors, and to help the state and patients obtain innovative medicines,” emphasized Taisa Herasymchuk, Director of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials.
In total, 10 seminars were held during the year, in both online and offline formats; almost 500 attendees completed the course and received certificates.
