Local and EU-QPPVOne of the most important services offered by AXPHARMA is the outsourcing of pharmacovigilance for client companies when this work is required by the relevant authorities
At AXPHARMA, these services will only be carried out by fully trained pharmacovigilance professionals who can ensure the utmost rigor in all types of regulatory situations, whether at European or national levels.
AXPHARMA is currently managing about twenty outsourced mandates at the European level (EU-QPPV) and an equivalent number at the national level (mainly in France, the Benelux and Italy : local QPPV).
In the framework of an outsourcing mandate at the European level, AXPHARMA can take on the entire EudraVigilance process, including the preparation of a Pharmacovigilance System Master File (PSMF) and the settings for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
Amongst the roles inherent in his position, a European Qualified Person Responsible for PharmacoVigilance (EU-QPPV) must ensure adequate monitoring for the detection of signals of adverse effects, as well as the drafting of:
• pharmacovigilance reports
• risk management plans
• any studies on risk minimisation that need to be prepared
• any Post-Authorisation Safety Studies (PASS)
The EU-QPPV also supervises the activities of subsidiaries and/or distributors and can be involved in drug re-evaluations initiated by the Pharmacovigilance Risk-Assessment Committee (PRAC) or a national agency.
All these tasks must be carried out according to the requirements set out in the EMA’s Good Pharmacovigilance Practices and national guidelines.