Pharmacovigilance System Master File

Pharmacovigilance System – Pharmacovigilance System Master File

00:00 Intro
00:10 Pharmacovigilance system master file
01:52 Structure of the pharmacovigilance system master file
02:26 Content of the pharmacovigilance system master file
03:51 Section on QPPV
05:08 Section on the organizational structure
07:12 Section on the sources of safety data
07:53 Section on computerized systems and databases
08:42 Section on pharmacovigilance processes
09:04 Section on pharmacivigilance system performance
10:17 Section on quality system

Ref 1) EU GVP Module II – Pharmacovigilance system master file (Rev. 2)

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