EMIG Regulatory Group October Meeting – GPvP Inspections

Thursday 18 October, 2018 starting at 14:00-16:00

IQVIA, 210 Pentonville Road, London N1 9JY, UK

“The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) completed 37 Good Pharmacovigilance Practice (GPvP) inspections during the 12 months to 31 March 2017. The inspections generated a total of 150 major findings, averaging at just over four per inspection. This figure is a notable increase compared with the previous 12-month period, with findings relating to quality management and the maintenance of Reference Safety Information accounting for much of this.”

In this session you will hear from MHRA and Industry covering best practice for GPvP inspections. This will be an interactive session so please come prepared with your own experiences.

The following topics will be included:

  • MHRA experience – good and bad examples
  • Common issues – where does industry need to improve
  • Role of Regulatory Affairs in a PV inspection – MHRA view and experience from the attendees
  • How does MHRA prepare for an inspection
  • How does industry prepare for an inspection

Registration can be found here

It is important that a name is provided for each ticket/registration as this is required by the venue for security purposes on the day.

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The Location

IQVIA, 210 Pentonville Road, London N1 9JY, UK

Event Location is here:
IQVIA, 210 Pentonville Road, London N1 9JY, UK

Published on 13. September 2018 in

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