Ateneo - UPO

The course focuses on the description of the regulatory principles that regulate the testing and registration of equivalent drugs of molecules produced by chemical synthesis (generic) and those produced by biotechnological procedures (biosimilars). Pharmacoeconomic aspects are also addressed with a view to the sustainability of the National Health Service. The students are also provided with hints on the new frontiers of therapy such as cellular and gene therapies, and how access to these therapies is linked to an adequate use of generics and biosimilar medicines.

Students are oriented toward the consultation of official sources i.e. EMA or AIFA and of the scientific literature concerning the topic covered by the course.

To provide the student with knowledge and methodological tools to understand the value of the drug even beyond the clinical impact, in view of the sustainability of the National Health Service

None. It is strongly suggested that the student has already positively performed the following courses: Biochemistry, Physiology, Pathology, Biology, Anatomy, as well as all the Pharmacology classes included in the study plan

The course contents will be transmitted through oral presentations supported by explanatory multimedia about the different topics included in the program. It will be stimulated the active participation of the student through the recall of concepts already addressed in other courses, which relate to various aspects of the drug and its economical value.

None

Written test.The student will be asked to produce a short essay that deals with a topic chosen in a group of 10 themes proposed at the end of the course

Generics: experimental, regulatory and pharmacoeconomic principles. Biosimilars: biotechnological drugs, experimental, regulatory and pharmacological principles. Innovative therapies: definition and sustainability

Ideally, at the end of the course the student has to know the pharmaco-therapeutical approach to the different pathologies, and has be able to give advices to patients and to develop control capabilities. Finally, he/she should have enough skills to follow the continuous evolution of pharmacology and pharmacotherapy.