30 participants attended the seminar on bioavailability and bioequivalence at the Center and received certificates. This is already the second group to complete the training course on the topic “Changes in the current legislation of the EU and Ukraine and prospects for further changes”.
The event took place on 15 May offline, under the guidance and organization of the Agency for Methodological and Scientific-Practical Work of the Center.
Welcoming those present, the head of the Agency Oleksandr HUDZENKO presented the work of the Center as a provider of professional development (PD) for medical and pharmaceutical workers, the program and speakers of the bioequivalence seminar, announced further training within the Center’s program of educational events, and encouraged participation.
The seminar speakers — Nadiia ZHUKOVA, Head of the Department for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center, and Oksana NAHORNIAK, expert of the Department for Expert Evaluation of Materials on Generic and Other Medicinal Products — covered in detail for the attendees the issues of the training program, answered participants' current questions, and paid special attention to the practical aspects of the course.
Визначення біодоступності та оцінка біоеквівалентності є важливими елементами при розробці та державній реєстрації лікарського засобу. Дослідження доказу біоеквівалентності двох препаратів мають важливе значення як на етапі нового препарату, так і в післяреєстраційний період. Тема біоеквівалентності є важливою для керівників напрямів, які займаються розробкою лікарських засобів, плануванням і проведенням досліджень, формуванням реєстраційного досьє для подальшої реєстрації ЛЗ.
In conclusion, Nadiia ZHUKOVA encouraged those present to join the upcoming seminars in the bioequivalence series, for which the Center is currently recruiting participants:
- Comparative pharmacokinetic studies;
- Biowaiver based on the Biopharmaceutics Classification System;
- Bioavailability and/or bioequivalence studies depending on the type of medicinal product;
- Immediate-release and modified-release generics.
Upon completing the course, all participants received certificates.
Please note that the next training seminar will be held at the Center on 07 June 2023 – the first on the topic of health technology assessment in Ukraine, "HTA as a Tool for Assessing the Value of a Medical Technology." Details and registration here.
