Purpose of the seminar – to give participants a systematic understanding of the requirements for demonstrating bioequivalence; the planning, conduct and evaluation of comparative pharmacokinetic studies; and the preparation of materials for state registration of medicinal products in Ukraine, taking into account current requirements and typical errors.
About the event: demonstrating bioequivalence is a key requirement in Ukraine and worldwide for demonstrating the similarity of the properties of a generic medicinal product to the reference product. To demonstrate bioequivalence, comparative pharmacokinetic studies and a biowaiver based on the Biopharmaceutics Classification System (BCS) are used. At this seminar we will talk in detail about everything related to bioequivalence and comparative pharmacokinetic studies. Participation in the training will allow participants to familiarize themselves with the current requirements, improve the quality of planning and conducting studies and of preparing materials, and minimize risks during state registration procedures.
Who is it for? The event will be useful for applicants, regulatory affairs and medicinal product development specialists, researchers, and anyone who wants to update their knowledge and avoid typical mistakes in registration procedures.
Organizers: Agency for Methodological and Scientific-Practical Work of the Center (hereinafter – the Agency) in cooperation with specialists of the Bioavailability and Equivalence Assessment Department.
Speakers: Oleksandr HUDZENKO, Head of the Agency, Doctor of Pharmaceutical Sciences, professor, Honored Healthcare Worker of Ukraine; Nadiia ZHUKOVA, Director of the Department of Bioavailability and Equivalence Assessment, Candidate of Pharmaceutical Sciences; Oksana NAHORNIAK, Head of the Bioavailability Assessment Division.
In the seminar program
- Everything about generics and hybrids. Which other types of applications for state registration and which features require attention
- Approaches to selecting and justifying a reference product. Typical errors. How to find information. Search examples
- What to do if a medicinal product has several dosages? Examples of different situations (mono and combination medicinal products)
- Decision-making algorithm: whether generic, hybrid, or fixed-dose combination.
- Pharmaceutical equivalence, comparative pharmacokinetic studies, the BCS-based biowaiver procedure, etc. Examples of different situations.
PROGRAM (pdf)
Format: Offline
After the training, participants will receive certificates.
Registration: Fill out the application and send it in doc / docx format to the Agency’s email address: amsw@dec.gov.ua
Contact person
Svitlana Borodai
Leading Specialist of the Agency
tel.: +38 (044) 202-17-00 (2251)
e-mail: borodai@dec.gov.ua
We will be glad for your participation and feedback!
The seminar is held as part of the training events of the State Expert Center of the Ministry of Health of Ukraine.
The aim is to help raise the level of professional awareness and develop key competencies of healthcare professionals. The Center’s training activities include a series of educational events – from workshops to specialized thematic webinars, both online and offline.
