Drug Safety and Pharmacovigilance, 7.5 credits

About the course

This is a continuation course based on the same format as the introductory course (Preclinical Safety Assessment and Pharmacovigilance) but a more comprehensive textbook will be used. We will discuss the principles of benefit/risk profiling of drugs and the safe use of medicines. The course is suitable for those who want to work with adverse drug event reporting and drug safety.

The course will focus on

• risk management and communication
• adverse event reporting and methods in pharmacovigilance
• the importance of genetic variation for adverse drug reactions
• serious adverse drug reactions
• risk/benefit profiling of pharmaceutical drugs especially biologicals and vaccines as well as pharmaceuticals and 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 and contains no compulsory campus meetings. Lectures are recorded and organised as video/audio sessions and are available on a web-based teaching platform. The students are offered supervised studies via the same teaching platform. This platform is also used for individual assignments, group exercises and discussions. Some of these assignments and exercises are mandatory and the participants are offered general or individual feedback on these moments. The participants and teachers communicate via the website and via email. A forum for discussion is also available. Examination will be in the form of web-based tests or individual assignments. In order to participate in this course you must have access to a computer with a rapid internet connection and headset with microphone.