Necessity of an EU QPPV?
We have the availability to provide you with an EU Qualified Person for Pharmacovigilance (QPPV) or QPPV Deputy/ dQPPV within (veterinary) medicines. For human medicines a physician is on the background available, complying the Directive and Guideline.
Within (veterinary) medicines, a EU QPPV will be available 24/7 for Marketing Authorisation Holder’s and Authorities.
Maintaining the Eudravigilance/ EVVET Database for incoming Adverse Events.
Also there is a possibility for an interim External Pharmacovigilance or Regulatory Affairs (Veterinary) consultant and contact for the Authorities necessary for Distributors within the EU.
Based on a Non Disclosure Agreement.