Registration of Medicinal Products (ZFTK_026)
About Study Course
Objective
1. To provide an overview of the role of marketing authorisation to ensure safety, efficacy ad quality as part of the the pharmaceutical regulation, within a life cycle perspective.
2. To promote the acquisition of practical skills for the preparation of documentation for the marketing authorisation application 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, English, public health, pharmaceutical legislation, ethics and bioethics, toxicology, clinical epidemiology, good clinical practices, good laboratory practices, good manufacturing practices, quality assurance, pharmacovigilance.
Learning outcomes
After successful completion of the requirements of the study course, students will have acquired knowledge that will allow:
1. Understand the importance of the marketing authorisation to ensure safety, efficacy and quality.
2. Understand the essence and meaning of the marketing authorisation process as part of the regulation of pharmaceuticals.
As a result of completing the study course, students:
1. Will be able to apply knowledge about the preparation of the marketing authorisation documentation of medicinal products with the requirements of the European Medicines Agency;
2. Will be able to analise the implication of the marketing authorisation in the life cycle of medicinal products from the development, use in the health systems and by individual patients and pharmacovigilance;
3. Will be able to correctly present the results of their practical work.
As a result of completing the study course, students will be able to to apply the rules and regulations for the marketing authorisation of medicinal products in the preparation of registration documentation and assess the importance of marketing authorisation in ensuring safety efficacy and quality for different stakeholders.
