Objectives

To enable students to develop an understanding of current practice in identifying adverse drug reactions and safety signals
To be able to classify events, identify signals and understand the follow-up procedure

Topics covered:

1. Definition of adverse drug reactions - type of ADRs
2. Detection and recognition of adverse events in clinical trials
3. Adverse event coding principles and differences
4. Spontaneous reporting databases
5. Principles of signal detection on electronic health care databases
6. Risk management plans