Author Archive for: Steen

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How do I remove an EU QPPV/RP role?

eudravigilance-registration-frequently-asked-questions_en EU QPPV/RP roles should be removed on their last day of work at that organisation. There are 2 ways to remove the role:  Roles can be removed by TDs of the organisation, or the EU QPPV/RP themselves, by going to EMA Account Management portal> EV Role admin tab.  Roles can be removed by the […]

QPPV indemnification

The role of the QPPV is defined in EU regulations and the in the Good Vigilance Guidelines (GVP). The person that takes on the role as EU QPPV also take on a great personal responsibility as the EU QPPV is responsible for all safety related activities globally for the marketing authorisation holder (MAH) towards EMA […]