Introduction to the Registration of Medicinal Products (ZFTK_042)
About Study Course
Objective
1. To promote the acquisition of knowledge and formation of understanding of dosage form development, manufacturing of medicinal products, manufacturing process validation, dosage form quality assessment.
2. To promote the acquisition of practical skills for the preparation of documentation for the registration of medicinal products.
Prerequisites
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, physical pharmacy, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, pharmacology. Knowledge of human anatomy, normal physiology and English is desirable.
Learning outcomes
After successful fulfilment of the requirements of the study course students will have mastered knowledge, which will allow:
1. To understand the importance of the dosage form development process.
2. To understand the nature and importance of the medicinal product registration process.
As a result of mastering the study course, students:
1. Will be able to apply knowledge on the preparation of documents for the registration of medicinal products.
2. Will be able to assess the compliance of medicinal product registration documents with the requirements of the European Pharmacopoeia and the guidelines on the quality of medicinal products.
3. Will be able to present the results of one’s practical work correctly.
As a result of completing the study course, students will be able to appreciate the importance of the rules for the registration of medicinal products in the preparation of registration documents.
Study course planning
| Study programme | Study semester | Program level | Study course category | Lecturers | Schedule |
|---|---|---|---|---|---|
| Pharmacy, FF | 6 | Master’s | Limited choice | Anna Lece |
