Basic Principles of Clinical Trials and Drug Registration (FLK_047)
About Study Course
Objective
Introduce students to the most important aspects of planning, organising and managing clinical trials and publishing their results. Develop skills in interpretation and analysis of the clinical research results. Provide an insight into the documentation required and legal basis for the registration of medicinal products.
Prerequisites
General pharmacology, search and analysis skills of research materials.
Learning outcomes
Upon successful completion of the course, the student will have acquired knowledge that will allow: 1. Understand why and how clinical trials are conducted and who assumes responsibility for conducting and/or financing a clinical trial; 2. Provide information on the discovery of new medicines, the registration process and the launch of medicinal products into the market; 3. Differentiate between bioequivalence and therapeutic equivalence, generic and original drugs, megabrands; 4. Explain the nature of cost-efficiency in pharmacology; 5. Be competent in the principles of communication and ethics of the doctor and the pharmaceutical industry.
Students will be able to evaluate clinical trial documentation, monitoring of clinical trials, and assess the relevance of clinical research to the principles of good clinical practice; will have a good knowledge of the European Union (EU) Clinical Trials Register in EU Member States and Iceland, Liechtenstein and Norway; will be able to find information on ongoing phase II-IV studies in adults and all paediatric clinical trials.
On completion of the course, students will be able to apply their theoretical knowledge of the clinical trial process, the procedures required to conduct the study, permits, certificates of good clinical practice and good manufacturing practice. Will be able to independently obtain, select, and analyze research information by the following search parameters: country, age, gender, and study phase, study status, diagnosis, etc., as well as the possibility to contact the sponsor of the particular study, if necessary. Will demonstrate a scientific approach to solving topical issues, as well as to specific literature.
Study course planning
| Study programme | Study semester | Program level | Study course category | Lecturers | Schedule |
|---|---|---|---|---|---|
| Medicine, SSNMFz | 10 | Master’s | Limited choice | Irēna Teterina | |
| Medicine, SSNMF | 9 | Master’s | Limited choice | Irēna Teterina | |
| Medicine, MF | 9 | Master’s | Limited choice | Irēna Teterina |
| Study programme | Study semester | Program level | Study course category | Lecturers | Schedule |
|---|---|---|---|---|---|
| Medicine, SSNMF | 10 | Master’s | Limited choice | ||
| Medicine, SSNMFz | 9 | Master’s | Limited choice | ||
| Medicine, MF | 10 | Master’s | Limited choice |
