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EUQPPV for human medicinal products

As provided for by Directive 2001/83/EC as amended, and by the Good Pharmacovigilance Practice (GVP), the Marketing Authorisation (MA) holder shall have permanently and continuously at their disposal an appropriately qualified person (QPPV) responsible for the pharmacovigilance system in the EU.

The EUQPPV is responsible for the establishment and maintenance of the pharmacovigilance system for the MA holder, and therefore has access, ensures and verifies that the information reported in the Pharmacovigilance System Master File (PSMF) accurately describes the pharmacovigilance system.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, with several experts with appropriate training and experience to assume the role of EUQPPV e Deputy.

Moreover, thanks to its international cooperation with several consultants in the EU countries, Di Renzo Regulatory Affairs can create a pharmacovigilance network with the Local Contact Points located in the company’s countries of interest. This enables companies to have a specific pharmacovigilance network for their products and for the countries where these are authorised.