Brexit and Pharmacovigilance: Notes from the DIA QPPV Conference
Delegates from the Acorn Regulatory clinical team are attending the 11th annual DIA QPPV forum in London. One of the main talking points at the conference has been the issue of Brexit and the impact that it will have on the role of the QPPV.
Mick Foy, Group Manager at the Vigilance Intelligence & Research Group at MHRA was one of the main speakers at the first day of the forum. He was discussing the consequences of Brexit on Pharmacovigilance for QPPVs. This is a topic that has elicited significant interest from the regulatory and PV community. There has been much conjecture regarding what might happen once the UK leaves the European Union.
Speaking at the DIA QPPV forum at The Crystal Conference Centre in London, Mick Foy spoke of how the UK has been a key stakeholder in helping create the current EU PV Legislation. Because of this working relationship and the role that the UK has played in creating the current legislation, it is unlikely that the MHRA will seek to change much of what is done today in routine PV activities. Nonetheless, the MHRA is likely to insist on a local QPPV resident in the UK responsible for UK PV activities. Furthermore, there will be a need for a PSMF specifically for UK MAAs.
While there is much uncertainty around the impact Brexit will have on individual MAHs, nonetheless companies will have to continue to ensure patient safety is not compromised by the activities associated with Brexit.
If you would like to talk to us about the implications of Brexit on QPPV’s and the pharmacovigilance function in your company then get in touch with us today. We have provided expert analysis and assistance to many companies seeking to navigate the Brexit maze. Contact us today on 00353 52 61 76706 or simply complete your details below and we will get back to you.