Tina
★    

India,
2013-07-02 16:07
(4745 d 19:36 ago)

Posting: # 10912
Views: 1,564
 

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

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
UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
308 visitors (0 registered, 308 guests [including 16 identified bots]).
Forum time: 11:43 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5