The topic is devoted to the specifics of conducting clinical trials of medicinal products in Ukraine.
The online training is conducted by the Center's Agency for Methodological and Scientific-Practical Work, headed by Doctor of Pharmaceutical Sciences, Professor, Honored Healthcare Worker of Ukraine Oleksandr Hudzenko. Presentations and course materials were delivered by specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials – Department Director Taisa Herasymchuk and Head of the Division of Specialized Expert Evaluation of Preclinical and Clinical Trial Materials Olha Smoliar.
The course covered key theoretical and practical aspects of clinical trials of medicinal products:
- types and phases of clinical trials. The latest study designs depending on the number of products and indications;
- the regulatory framework in the field of clinical trials, taking into account current and new legislation on medicinal products, the principles of good clinical practice (GCP), the guidelines of EMA, ICH, and leading pharmacopoeias;
- KV values for the country, healthcare sector, patients;
- conditions for conducting clinical trials in Ukraine – where they are conducted, who is involved;
- a detailed checklist: how a practicing physician can become a researcher and how a patient can become a clinical trial participant.
The Center, as a CPD provider, is holding a seminar on clinical trials of medicinal products for the first time and plans to develop this topic further, – stressed the head of the Agency Oleksandr Hudzenko at the opening of the event. He announced the nearest CPD seminars in this area as early as March and June of this year on the following topics:
- regarding the activities of ethics committees at treatment and prevention facilities conducting clinical trials of medicinal products (March 2024)
- regarding the organization of trial sites (TS) at healthcare facilities (June 2024).
Participation in this course and successful completion of the test make it possible to gain valuable knowledge from the specialists of the Center as a specialized institution, as well as to earn additional points for a professional portfolio, – emphasized O. Hudzenko.
In total, in the first half of the year the Center plans to hold 9 CPD trainings in various areas: pharmacovigilance, bioavailability and bioequivalence, health technology assessment, etc. We recommend following the calendar on the Center's dedicated page and booking dates in your planners in advance.
What makes professional development training at the Center unique:
- these are the only topics on the market within the scope of authority
- focus on international guidelines and best global experience
- high-quality content adapted to the needs of the audience
- an effective combination of theory and practice
- qualified and competent speakers at the national regulatory authority level
- a convenient online format that allows learning without interrupting the work process
- certificates and +10 points for each seminar toward attestation.
