The role and importance of the UK National Contact Person for Pharmacovigilance and how it should add value to your organisation

Jackie Roberts gives her thoughts on the role of the UK NCP

“Before Brexit I was an EEA-QPPV responsible globally for pharmacovigilance for a large portfolio of (over 1000) products, however, the UK voted to leave the EU and the MHRA began to extract themselves from the European licensing system leaving the industry in the UK to wonder what would happen next. At first it appeared that the MHRA would require a UK-QPPV who resided and operated in the UK, so I transitioned to this and a separate EEA-QPPV was put in place. However, over time the role evolved and the MHRA confirmed that the EEA-QPPV could also act as the UK-QPPV and not operate/reside in the UK provided that there was a UK National Contact Person for Pharmacovigilance, named and available.  My role then evolved to that of a UK-NCP.

So what does the UK-NCP do and how do they add value? At the very basic level they act as a postbox between the MHRA and the company. They report into the EEA-QPPV. The UK NCP must also have access to the PSMF and adverse event information on products within the UK portfolio. For me, adding value is the most important thing, I am currently the UK-NCP for a branded UK company and I see my role far more than just acting as a postbox. How I add value is:

·       Involvement in creation and maintenance of the PSMF and pharmacovigilance quality management system – this is a key area for me to add value by utilising the knowledge and experience of many years working in pharmacovigilance.

·       Support for the EEA-QPPV – by providing a sounding board for discussion of issues and supporting them with documentation review and company meetings. We have regular meetings and I am also involved in the Safety Board and Company Compliance meetings.

·       Being the source of UK regulatory intelligence – as part of my role I provide the EEA-QPPV and the company a monthly report summarising the changes to UK legislation and how this could impact on them, and I also review leading UK sites such as the ABPI, PAGB and PMCPA . From feedback received this has been of great use to both the QPPV and the company senior management.

I am adamant, as is Lisa, that the role of the UK-NCP must be value-adding. Both of us have QPPV and NCP experience and would be very happy in discussing how we can add value to your company and we can act either as your UK-QPPV or UK-NCP.”

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