Requirement for QPPV in EU clinical trials [Regulatives / Guidelines]

posted by Tina – India, 2013-07-02 16:07 (4740 d 23:33 ago) – Posting: # 10912
Views: 1,554

Dear forum Members,

Kindly help with the below query please:

Is it a requirement in the EU to have a QPPV for PhV reporting in clinical trials by an applicant who doesnt hold MAH for the molecule in the clinical trial?

Thanks for the kind response

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