As required by European and Italian regulations, every AIC holder must have, on a stable and continuous basis, a Qualified Pharmacovigilance Person (QPPV) and an established pharmacovigilance system.

Since 2008, VI.REL has been acting as a Service Provider capable of meeting the different needs of Clients: from comprehensive management of Pharmacovigilance activities to spot activities.

Below is a list of the services we offer to our clients:

• Qualified Person for Pharmacovigilance (QPPV) and Local Contact Person (LCP).
• Pharmacovigilance Physician
• Support in Pharmacovigilance activities, including the drafting and maintenance of PSMFs and related SOPs
• Case management and follow-up
• Indexed and non-indexed literature search
• Signal management and Signal Detection Report writing.
• Management of the database “Art 57”
• Pharmacovigilance Training
• Safety Database Management,
• Drafting of risk-management plan (RMP) and Periodic Safety Update Report (PSUR)
• Pharmacovigilance Audits, Due Diligence