EEA & UK Qualified Person for Pharmacovigilance
Under regulations in both the European Union and United Kingdom, each Marketing Authorisation Holder needs to have a named individual who is personally responsible for the safety of the products marketed by that company. The requirements for this role have been in place in the EU since 2004, and the UK specific role from January 2021. The named individual is required at the point of submission of the Marketing Authorisation Application, and needs to be permanently and continuously available 24/7.
At Diamond, as part of our full PV system we are able to offer our clients the services of a named QPPV in both the EEA and UK. The QPPV is fully integrated with our PV system, overseeing all the key elements of our approach and key documentation such as the Risk Management Plan and Pharmacovigilance System Master File (PSMF).
Please contact Catherine at email@example.com or +44 (0) 203 911 9410 if you would like to talk to us about becoming your EEA or UK QPPV.
In certain markets in the European Union and other global markets, there is a requirement for the nomination of a pharmacovigilance person at national level. The role of these 'local QPPVs' or 'National Persons Responsible for Pharmacovigilance' (NPRPs) are required from countries such as Belgium, France, Germany and Spain to Kazakhstan.
Diamond has a network of partners able to act as Local QPPV in markets around the world.
TALK TO US
Catherine Kenny is our lead EEA QPPV based in Dublin, and supported by a team of QPPVs in the UK and Europe.
or speak to Catherine on +44 (0) 203 911 9410