Regulatory Sciences and Economics of Pharmaceutical Industries

To provide the students with knowledge of the European regulations governing the manufacturing and marketing authorizations for originator medicinal products, including biotechnological and advanced therapeutic products as well as generics and biosimilars. Regulatory aspects behind patents, proprietary data protection and medicinal products advertising will be discussed. In addition, management aspects relevant to the organization of pharmaceutical companies, particularly towards research and development activities, business development and market access will be discussed.

The student will gain regulatory expertise on how to manage the development and go-to-market strategy of medicinal products as well as to the associated economic aspects.