Formulation and Regulatory Affairs of Health Products and Pharmaceutical Regulatory Affairs and Patents

The purpose of the course is to introduce the students to knowledge of the relevant European Community legislation concerning Marketing Authorization (MA), as required before the introduction on the market of a medicinal product. In particular biotechnological medicinal products, including biosimilars, are discussed. The legislative aspects of pharmaceutical patent will also be analyzed.
Moreover, the course provides knowledges to understand the right administrative classification and to evaluate the conformity to national and European rules concerning production, placing on the market and distribution of health products, such as cosmetics, food supplements or food for specific groups.

The student will acquire the knowledge about legislative aspects of medicines for human use and the main health products.