A comprehensive package of PV Services
Local Qualified Person for Pharmacovigilance
We provide local QPPV services in EU member states that require a Local QPPV.
In 18 European Union countries there is a requirement for a local QPPV who is the local responsible person for pharmacovigilance in a EU member state. The Local QPPV reports to the EU QPPV who is responsible for all activities of a Marketing Authorization Holder that sells or have applied for a marketing authorisation in any EU country.
Czech Republic *
* These countries require local QPPV already at the time of market authorisation for the EU. For Germany possibly on if local Market Autohrisation. Always check with the regulators as the requirements keep changing
The QPPV must be in place before a marketing authorisation application is filed in the EU. The local QPPVs must be in place in some counties as soon as the marketing authorisation is granted and in other countries when the product sales have started.
In addition to the general responsibilities for drug safety the local QPPV is usually also handling literature searches in the local language.
Through a network of experienced drug safety professionals around the European Union we are able to support a marketing authorisation holder with necessary local QPPV services
The concept of Risk Management was first standardized in the ICH E2E document in 2004 which defines Pharmacovigilance Planning accepted in all 3 ICH regions. In 2006 the European Union introduced Risk Management Plans (RMP) and it was updated with the introduction of the Good Pharmacovigilance Practice legislation in 2010/2012 and latest in 2017
Safety System Implementation
Implementation of a compliant Safety Systems require expertise in both Drug Safety, Technology and Validation. We can support you throughout the process