In spite of the exhaustive GVP guidance very little has been writtenĪbout, and there is no published consensus on, how this role The extensive role and responsibilitiesĪre described in GVP Module I Section I.C.1.3. Is the most important defined natural person in the EU The EU/EEA qualified person responsible for pharmacovigilance Keywords: Qualified person for pharmacovigilance Deputy To provide all necessary support to enable the QPPV to discharge his/ QPPV, and the management of the MAH is obliged by the legislation Training toįulfill these responsibilities is required as part of the toolkit for the Personal view on how a QPPV should implement oversight andĪpproach delegation, which can be applied in practice. On our own experience and good business practice, we present a Have they been agreed within the pharmaceutical sector. Legislation, what they mean in reality has neither been defined nor Regardless of how these responsibilities appear in the Long list of tasks, implementation of which requires oversight andĭelegation. System of a Marketing Authorization Holder (MAH) in the European (QPPV) is personally accountable for the pharmacovigilance quality The EU/EEA Qualified Person Responsible for Pharmacovigilance
