Latest News

Pharmacovigilance Inspections

28/1/2010

The MHRA have recently implemented their Risk-based Pharmacovigilance inspection programme, based on an analysis of Compliance Reports submitted by MAHs.

Completion of a Compliance report allows the MHRA to assess the level of control of risk that an MAH has. The MHRA then use this assessment in order to prioritise their inspection scheduling.

If you have received notification of inspection Wainwright Associates can assist in your preparation for the inspection in a number of ways - see our Pharmacovigilance Services pages.