The presentation will provide an introduction to the purpose and value of evaluating risk minimisation measures (RMMs) with a focus on European regulatory guidance. Examples of how RMMs evaluations are conducted in different therapeutic area will be presented. The challenges posed by the COVID-19 pandemic to the healthcare delivery systems globally, including educational interventions and ongoing PASS will be discussed together with regulatory measures undertaken.
- GVP XVI revision 3 – impact of updates on risk minimisation and effectiveness evaluation
- Measuring the impact of risk minimisation interventions: PAS studies to measure the impact of risk minimisation measures
- Future perspective: use of digital tools in the (post) pandemic era