The revised GVP module XVI on risk minimisation measures (RMM) will come into effect in Summer 2024.

The focus of this interactive Information Day will be to exchange first experiences on its implementation from Regulators, Industry, Patients as well as Health-care professionals perspective.

Different aspects of the revised guideline will be discussed such as the nature of the RMM, its lifecycle management, the specifications of the RMM tools and the criteria for requesting aRMM, timepoints, and metrics. Furthermore, the success thresholds of RMM effectiveness evaluation, impact of results of RMM effectiveness evaluation, RMM materials in Risk Management Plans (RMPs), the active role of the Marketing Authorisation Holder (MAH) as well as the coordination of RMM for generic products and the national approval of RMM will be reviewed.

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 04 November latest. Submit your questions to emaevents@diaglobal.org.