Local QPPV Services

We provide Local QPPV services in France as required by local legislation. The Local QPPV:

  • Acts as a single point of contact for the French Health Authorities
  • Provides local language support/translations
  • Assist the MAH with the collection and reporting of ADRs and aggregate safety reports
  • Assist the MAH with the implementation of risk minimisation measures at a national level

We will select and screen local journals and/or databases for adverse reactions relating to the products being monitored as well as any other information that may be relevant for the critical risk/benefit evaluation and for the preparation of aggregate safety reports. Data screened includes:

  • Case reports
  • Summaries and Publications from congresses
  • Published studies containing new safety findings

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