Preclinical Safety Assessment and Pharmacovigilance

7.5 credits

Course, Master's level, 3FX211

Spring 2024 Spring 2024, Flexible, 50%, Distance learning, English

Spring 2024 Spring 2024, Flexible, 50%, Distance learning, English For exchange students

About the course

This introductory course provides a concise overview of the principles of preclinical safety assessment and pharmacovigilance. We will discuss the assessment of drug candidates, risk/benefit profiling of drugs and the safe use of medicines. The course is suitable for those who want to work with preclinical toxicity testing or adverse drug reaction reporting and pharmacovigilance.

The course will focus on the principles of

  • mechanisms of toxicity and adverse drug reactions
  • preclinical toxicity testing
  • phase 1 clinical trials
  • drug recalls
  • risk/benefit assessments of drug candidates and pharmaceutical drugs
  • pharmacovigilance.

We will discuss the safety of drug candidates and pharmaceutical drugs based on toxicity testing, clinical trials as well as on general use on the market. The course will not cover the detailed regulatory toxicity testing and pharmacovigilance guidelines and regulations set up by medicine agencies such as 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 internet connection and headset with microphone.

The course is given in collaboration with the Uppsala Monitoring Centre (UMC). UMC is responsible for the management of the WHO Programme for International Drug Monitoring and the WHO Global ICSR Database.