When marketing medicinal products in the EU, it is mandatory to appoint a European Union Qualified Person for Pharmacovigilance (EU QPPV), responsible for the compliance of the pharmacovigilance system with the EU regulations.
This essential role can however be outsourced to professionals, thus saving costs and resources.
Di Renzo Regulatory Affairs is an experienced regulatory consultancy organisation that can provide EU- based QPPVs, to support MA holders in the compliance with pharmacovigilance requirements.
Our QPPVs will support you in the following activities:
- data submission to the European Medicines Agency (EMA) and other European competent authorities according to the GVP
- provision of responses and information to EMA and competent authorities in case of requests regarding the product safety
- regulatory actions in case of any safety concerns
- advice on risk minimisation measures
- supervision of safety profiles
EU local pharmacovigilance representatives
Some EU Member States require the appointment of a pharmacovigilance responsible person at national level, the so called local representative or local QPPV.
For companies located outside the EU or in other Member States, the appointment of a local QPPV can be a difficult matter, as this should speak the local language to be able to interact with the local authorities.
Di Renzo Regulatory Affairs can act as local contact point in Italy to comply with national pharmacovigilance requirements.
EudraVigilance is the European data system to collect and manage suspected adverse reactions (ADRs) related to medicinal product marketed or still under development in the European Economic Area (EEA).
The EudraVigilance system allows to detect safety signals, promoting their monitoring and making tools available to create reports and assess safety data.
Di Renzo Regulatory Affairs can assist you with the EudraVigilance system, and offers the following services:
- Inclusion of Individual Case Safety Reports (ICSRs) in EudraVigilance.
Pharmacovigilance System Master File (PSMF)
When marketing medicinal products in the EU, it is mandatory to have a Pharmacovigilance System Master File (PSMF), describing in details the pharmacovigilance system of the MA holder, including its organisation, the relevant pharmacovigilance processes, the system performance, the quality system and the sources of the safety data. It also includes information on the QPPV as well as evidence of the compliance with the Good Pharmacovigilance Practices (GVP).
Di Renzo Regulatory Affairs can provide you with support to:
- prepare your Pharmacovigilance System Master File (PSMF)
- review and update any PSMF already in place
- maintain your PSMF so that it can be available at any time in case of requests by the competent authorities.
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