Preclinical Safety Assessment and Pharmacovigilance

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
• life cycle of innovative drugs
• pharmacovigilance.

In this course, you will gain insights into the safety considerations associated with both drug candidates and approved pharmaceuticals. The exploration encompasses a comprehensive review of preclinical and toxicological tests, clinical studies, and the safety of drugs already on the market. The course will illuminate the strategic approaches employed by the European Medicines Agency (EMA) to encourage research and the adoption of innovative methodologies in developing safe and efficacious medications through their whole life cycle.

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. The 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 an internet connection and a headset with a microphone.