Local and regional regulatory authorities are constantly updating safety information which requires reference safety data and labeling to be updated. This is time-consuming for a QPPV. iVigee has created a monitoring solution that performs these tasks.
iVigee can support you with PV training compliance, PV regulatory compliance (submission of ICSRs, aggregate reports, MA commitments, safety variations) and with compliance with internal standards.
The iVigee team can provide oversight to a local QPPVs network, act as a central point of contact for local QPPVs, consolidate deliverables from individual local QPPVs for the EU QPPV and monitor performance and compliance.
We can support the preparation of responses to competent authorities' requests, drafting, coordinating and medical input as well as act as an internal contact point for labeling changes (cooperation with the regulatory department). iVigee can also offer to monitor the progress related to a safety variation, agreed MA commitments, and escalation to EU QPPV, and monitor regulatory intelligence updates.
iVigee can offer support in long-term audit strategy (criteria, assessment matrix, audit cycle), in annual audit program (preparation for scheduled internal audits), and offers to act as "audit coordinator" in individual audits (negotiation of time, individual SMEs availability, document requests collection & release to auditor, minutes taker during an audit, etc.). CAPA management (coordination of preparation, monitoring of due dates, support in resolution) and audit/inspection-readiness training can be also handled by our team.
iVigee can carry the responsibilities of initial drafting of the SDEA, help with the review of SDEAs received from partners, maintain SDEA oversight/review cycle, and inform individual internal parties about the responsibilities implied by the SDEA.