Specifics of the pharmaceutical development of medicinal products as a guarantee of their quality and safety – the Center held a seminar-training for applicants and interested parties.
19 participants specializing in the development and registration of medicinal products in Ukraine took part.
The seminar topic concerned a relevant subject – the pharmaceutical development of medicinal products to ensure their quality and safety. After all, patients must be confident that they receive high-quality, safe, and effective medicines.
The speakers at the event were experienced medicinal product quality specialists of the State Expert Center – Svitlana Osadchenko, Director of the Pharmaceutical Activity Department; Petro Holodiuk, Head of the Division for Expert Evaluation of Quality Materials Submitted for Re-registration; and Oleksandr Burmaka, Head of the Center's Pharmaceutical Analysis Laboratory.
During the course, participants became familiar with:
- approaches to the creation, development and registration of medicinal products;
- the concept of quality assurance of medicinal products
- the safety profile of medicinal products within Module 3. Quality.
A wide range of issues was discussed – from the components of medicinal products and the specifics of approaches to the development of generic and original medicinal products, to container closure systems.
Information was provided on the regulatory requirements for the development and placing of medicinal products on the market.
Active questions and discussions that took place during the seminar confirmed the relevance of such events for applicants.
The event was organized and held by the Agency for Methodological and Scientific and Practical Work of the State Expert Center of the Ministry of Health at the Kyiv School of Economics. All participants received certificates upon completion of the seminar.
