Clinical Pharmacology, Advanced Therapies and Regulatory and Patent Aspects

The aim of the course is to present the students with the most important aspects of clinical discovery and final evaluation and commercialization of a drug. The main topics covered during the course will be the experimental, ethical, clinical aspects of drug discovery and use, its regulation and legislation.

At the end of the course, the student will be able to follow the entire development of a new active compound or pharmaceutical formulation, to understand how to design a clinical study needed for marketing the new drug, and what is the relevant European Community legislation concerning Marketing Authorization (MA) and patents of new medicinal products.