Basic Principles of Clinical Trials and Drug Registration

1.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.

1.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.

1.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.