Drug Safety and Pharmacovigilance

This advanced course is conducted in English and follows the same format as the introductory course (Preclinical Safety Assessment and Pharmacovigilance) but with two more comprehensive textbooks. The course provides knowledge about the principles of benefit/risk assessment of drugs and how to enhance safety in drug use. Throughout the course, you will work with signals initiated by various national authorities and learn about the specific safety measures issued to address these by the European Medicines Agency's safety committee (PRAC; Pharmacovigilance Risk Assessment Committee). The course will focus on * risk management and risk communication * adverse event reporting and other methods used in drug safety monitoring-pharmacovigilance * the importance of genetic variation for adverse drug reactions * safety signals and signal management within the EU * risk/benefit profiling of pharmaceutical drugs especially biologicals and vaccines as well as pharmaceuticals and the effects of genetic variation. This course does not cover the detailed pharmacovigilance guidelines or regulations set up by EMA and FDA or the web-based pharmacovigilance tools set up by these agencies. Furthermore, the course will not cover the detailed regulations for adverse event reporting within pharmaceutical companies. **Outline for distance course**: The course is entirely web-based. The course has a few mandatory Zoom meetings in the afternoons, where the teaching staff explains the basics of the course and its assignments. Instruction is delivered through video lectures via a web-based learning platform. This platform is utilised for individual tasks, group exercises, and discussions, some of which are obligatory. Participants receive general and individual feedback on exercises and submitted assignments. Communication between participants and instructors occurs through the learning platform and email, with a discussion forum also available for student discussions. The examination will be conducted through web-based tests or individual assignments. To participate in the course, you must have access to a computer with a fast internet connection and headphones with a microphone.