Table 2.

Mechanisms for stakeholder engagement events available to the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency[11]

Stakeholder mechanism
Written consultations (public and open to all citizens and organisations as announced on the EMA website, e.g. public consultations on guidelines and other policy documents, and/or announced to organisations of the EU stakeholder network, e.g. targeted reviews of planned safety communication documents)
Dedicated meetings (non-public meetings with stakeholder representatives, in particular patients and healthcare professionals, e.g. so-called ad hoc meetings and research oversight meetings)
Participation of additional scientific/clinical experts and/or patient representatives in a meeting of the Scientific Advisory Groups established for various therapeutic areas (non-public meetings)
Public hearings (open to all citizens and organisations as announced on the EMA website and provided to the public as life-broadcast)

EMA European Medicines Agency, EU European Union