What does the future hold for the qualified person (QP) post-Brexit? There has been much debate on this matter. We do know that all EU centralised marketing authorisations must be held by a legal entity within the EU and that QP certification and pharmacovigilance (PV) need to occur in the EU.
The role of the QP is already in UK law (SI 2012-1916) and the UK is expected to retain the role of the QP post-Brexit. It does mean, however, that EU QPs may no longer be able to accept certification by UK QPs and vice-versa. The result of all of this is that there will be a growing need for more QPs both in the UK and in the EU.
NSF has been running QP training courses for 28 years. With 177 training modules, more than 4,000 delegates and a pass rate of 96%, the company has just seen its 300th QP pass their viva! Congratulations global technical director and QP of health supply at Reckitt Benckiser Healthcare UK Alan Clark.
NSF currently runs 12 modules, meeting the requirements of the UK QP Study Guide, over a 21-month period. With the demand for this training increasing and delegates attending from overseas as well as the EU, additional courses will be launched from January 2019 in both London and Brighton. This will provide the opportunity for all 12 modules to be completed over a 12-month period, providing flexibility and choice of location to the delegate.
In June and September 2018, NSF ran a seminar in each of its new locations, which were well attended, and it received some great feedback on the new venues. Topics covered were a pharmaceutical law and Brexit update, as well as an overview of document simplification methods and techniques. There were plenty of discussions on the challenges that industry faces, with deviations and corrective and preventative actions (CAPA), serialisation, PV, data integrity and Annex 1 as some of the continuing topics named.
Each module is a stand-alone course and can be taken in any order. For those taking all modules, there will still be the opportunity to gain postgraduate qualifications from the University of Strathclyde.
The teaching and learning on the courses is highly interactive, using a combination of lectures, discussion scenarios and teamwork, which provide a context to help with decision-making, a prerequisite for the future QP. There are also additional site visits planned to pharmaceutical manufacturing facilities in the UK to see the real-life application of what has been learned.
Our next QP courses include: