We are resuming the cycle of thematic offline seminars for applicants – the first one was on bioavailability and bioequivalence.
The training topic is devoted to comparative pharmacokinetic studies of medicinal products and biowaivers for additional dosage strengths.
Participants include representatives of pharmaceutical companies involved in the development of medicinal products, the planning and conduct of studies, and the preparation of dossiers for medicinal product registration.
Specialists of the Department for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center, Nadiia Zhukova and Oksana Nahorniak, gave a course of lectures and practical sessions. The training was organized by the Agency for Methodological and Scientific-Practical Work of the Center under the supervision of Doctor of Pharmaceutical Sciences, Professor, Honored Health Care Worker of Ukraine Oleksandr Hudzenko.
During the theoretical part of the seminar, participants became familiar with:
- understanding of bioequivalence in the context of the new Law on Medicinal Products
- regulatory and legal principles of proving the generic status of medicinal products in Ukraine and worldwide, provisions of the new bioequivalence study guideline approved in Ukraine in February of this year.
- specific features of the requirements for proof of genericity depending on the dosage form, the relationship between pharmaceutical equivalence and bioequivalence
- approaches to the selection and justification of a reference product
- requirements and the latest updates to international guidelines on bioequivalence, EMA and FDA approaches.
Head of the Directorate Nadiia Zhukova presented the features of designs, standardization and evaluation criteria for comparative pharmacokinetic studies, taking into account their purpose, and demonstrated examples of various studies.
Oksana Nahorniak, expert of the Division for Expert Evaluation of Generic Products, addressed the issues of conducting the biowaiver procedure for additional strengths of medicinal products depending on their composition (mono/combination), and went through specific examples and problematic issues with the audience.
During the practical part of the session, participants together with the Center's specialists analyzed typical errors most often made in bioequivalence studies. They practiced solving specific tasks on proving the generic nature of medicinal products depending on the dosage form, as well as on dose selection.
Upon completion, they received certificates for the workshop they attended – the knowledge gained will help improve the efficiency of developing medicines and their analogues, adapt to new challenges and regulatory requirements, properly prepare dossier materials without errors and returns, and contribute to raising the quality level of the generic medicines market in Ukraine.
For your information – on 27 February, the Center will hold an online seminar with credit points in the continuous professional development system, “Important Issues Regarding Generics and Bioequivalence”. The training will be useful for medical workers and other healthcare professionals who wish to join in the discussion of issues of creating generics and proving their bioequivalence. So we invite those interested.
Details and registration via the link
