Aims: The course of ” European Pharmaceutical legislation ” aims to provide students with a basic understanding of the complex regulatory framework of the pharmaceutical sector in force at Community level. In particular, the main purpose is to make sure that the student knows how to operate in the field even where the rules are studied now will be superseded by others in the future.
Program: The pharmaceutical legislative framework is made up by Directives and Regulations as the basis for a general guideline for the EU community with the scope of setting up “harmonized standards” throughout the European Union and at the same time maintain an appropriate level of protection for public health.
The course aims to analyze in depth the rules governing the pharmaceutical sector, starting from those that regulate the development of a new product up to the rules relating to the introduction of the medicinal product in the market.
