Pharmaceutical Law

The objective of this course is to explore the legal framework that governs research on new drugs (clinical trials), drug production and marketing. The EU has developed detailed legislation in relevance, particularly with regard to clinical research. Recently a new Regulation has been adopted, with the aim to promote clinical trials in Europe focusing both on efficient protection of patient rights and on facilitating procedures with an integrated corpus of rules for all EU member states. New problems emerge and students will have the opportunity to address them in specific case studies.