The Center held the workshop "Biowaiver Based on the Biopharmaceutics Classification System," the third in a series of offline seminars devoted to bioavailability studies and the demonstration of bioequivalence of medicinal products.
Organizer: the Agency for Methodological and Scientific-Practical Work of the Center.
About 30 participants from leading pharmaceutical companies of Ukraine took part – managers and staff working in medicinal product development, study planning and conduct, and compilation of the registration dossier for the subsequent registration of medicinal products.
Opening the seminar, the Head of the Agency Oleksandr HUDZENKO welcomed the participants to the start of the new season of the Center's external training events as a professional development provider, presented the topics and areas of the upcoming trainings, and urged everyone to join and gain new and the most relevant knowledge in the field of development and circulation of medicinal products in Ukraine.
The seminar was conducted by experienced and highly qualified specialists of the Center's Department for Expert Evaluation of Bioavailability and Bioequivalence Materials – Nadiia ZHUKOVA and Oksana NAHORNIAK.
The course focused on current issues:
- approaches to the selection and justification of the reference product, typical mistakes;
- updated approaches to demonstrating bioequivalence under the biowaiver procedure based on the biopharmaceutics classification system (BCS) – the requirements of the guideline "ICH M9 Guideline on biopharmaceutics classification system-based biowaivers";
- updated requirements for determining the solubility of the active substance under the BCS;
- requirements for determining equilibrium solubility;
- updated requirements for excipients;
- specifics of preparing bioavailability materials (absolute bioavailability, mass balance, Caco 2);
- requirements for conducting and evaluating dissolution kinetics;
- requirements for validation of analytical methods;
- preparation of reports.
The seminar was one of the most practical in the series. Participants worked in groups and practiced building a sound algorithm for developing a generic medicinal product and demonstrating its bioequivalence through the biowaiver procedure based on the BCS. Together with the lecturers, they reviewed typical errors and received answers to questions
Upon completion, all course attendees received certificates.
As a reminder, participants can provide feedback on the seminar and an assessment of the knowledge gained to the Center by filling out the questionnaires received on the day of training and sending them to amsw@dec.gov.ua. In this way, the Center does its utmost to improve its training events and make them as effective as possible.
We invite you to follow the announcements of further training sessions and to register to participate.
More details on the website in the Center's Training Events section https://www.dec.gov.ua/
