New Organization First User QPPV/RP or Change of EU QPPV/RP

On September 25, 2019 EMA informed that sponsors need to notify EMA in case of new organization first user QPPV/RP or change of EU QPPV/RP.

If a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organization occurs, sponsors need to notify EMA.

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