Risk management plans for medicines include risk minimisation activities to inform and educate patients and healthcare professionals, and to help prevent or mitigate adverse effects. This session will explore why some medication risks need additional risk minimisation activities and what types of tools or activities may be included in a risk management plan as additional risk minimisation measures. How to implement, monitor, measure and report on the effectiveness of these activities will also be discussed. The session will include examples of activities and their execution, TGA representation and a look at how risk minimisation is handled in Europe.
Chairperson: Sue Ewart, Amgen