Before submitting your marketing application in Europe or the UK, thinking about the PharmacoVigilance System and its Qualified Person (QPPV) is key for successful product development – at the time of submission, a PV system must be in place and a QPPV must be declared.
In this session, we aim to guide your way through EU and UK requirements for QPPVs toward your marketing application and beyond, by answering questions such as:
Who can act as QPPV?
What authority will they require over the PV system and how is this authority represented?
What does a QPPV do on a daily basis through Marketing Authorisation Application, approval and the rest of the product lifecycle?
When and how should the QPPV be declared?
Where are the QPPV responsibilities detailed?
We will answer all your QPPV-related questions!
