Assessment of product safety and Pharmacovigilance (PV) system for UK entity of Pharma group of companies

Project Brief:

EPiC received a request from a large pharma group of companies that following a series of mergers and acquisitions was establishing a new UK entity and needed to establish a standalone PV system for the new entity in preparation for the transition.

The client had developed the standalone systems for the UK entity and had requested an onsite consultation visit to assess compliance and provide an opportunity for the team to experience responding to routine PV inspection requests in preparation for a MHRA GPvP inspection. 

What EPiC Did:

  • Our consultant worked with the site’s PV Director to develop and agree the scope and agenda for the visit to ensure there was a clear understanding of the planned objectives and required outcomes.
  • We conducted an onsite consultation visit to discuss and provide advice on the approach taken by the client in establishing the standalone PV systems. The visit included bespoke workshop sessions to discuss likely areas of interest during a MHRA inspection, potential compliance concerns, and also provided coaching in how to respond to inspector questions.
  • We provided a summary report of recommendations, compliance concerns and gaps that would need to be addressed in preparation for a MHRA GPvP inspection.

Client Feedback:

“Our consultant was very responsive and open to our direction, tailor making the workshop we had to meet our needs.”

“The report was clear.  We also received an initial summary straight after the consultation which was helpful.”