SFAK25008U Regulatory Science

The primary goal of this course is to provide students with a comprehensive understanding of the European Union's legal framework for medicinal products. This includes insight into the EU legal system and the legislative structure governing these products. Moreover, students will also gain an understanding on how EU pharmaceutical regulations are put into practice. This encompasses various procedural aspects, such as the application process for marketing authorisations, the conduct of clinical trials, orphan designation, paediatric development, and risk management.

Throughout the course, students will be introduced to diverse facets of the EU regulatory framework. They will gain insights into how the EU regulatory system functions and understand the various regulatory pathways and procedures involved in the life cycle of medicinal products. This understanding will be achieved through the analysis and discussion of specific sections of EU pharmaceutical directives and regulations, selected guidelines, real-world case examples, and in-depth studies in regulatory science. Regulatory science studies and case examples of regulatory decisions and procedures will play a key role throughout the course to substantiate the students understanding and reflections on the functioning of the regulatory system and its implications for industry, patients, and society.