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The MHRA's Beating Drum
So, it’s mid-November and Christmas is creeping up once again. It has been an exceptionally busy year at Red Line and we have had a bumper year of growth. Our client portfolio is looking healthy and our team of staff have grown in knowledge and size. It’s a positive way to start 2016.
On 6th November, I attended the MHRA GVPV Symposium which turned out to be an exceptionally informative and educational day. So, both time and money well spent, listening to advice by the MHRA inspectorate. Definitely, a must for any QPPV, Deputy QPPV or Pharmacovigilance auditors.
Most reassuring to learn was the fact that findings arising during MHRA inspections were pretty similar across the board of pharmaceutical companies, both large and small. So, it’s good to see that even though we may be a small outsourcing provider, we are not the only ones finding some of the requirements within the new legislation a challenge to interpret and implement correctly.
The day covered topics related to common inspection findings, self governance audits, signal management and risk minimisation. A great overview was provided on how other companies are managing their pharmacovigilance system master files.
My favourite for the day was related to expectations around managing reference safety information. This has been a huge learning curve for pharma companies as the scope of PV creeps into the realm of regulatory affairs. Over the years I have droned on and on about this issue, so as a QPPV it was a relief to hear the MHRA beating on the same drum.
On the upside, it was equally satisfying to hear that there is an awful lot we are getting right and that was really positive for me as QPPV and Managing Director. There is nothing worse than heading back to the office after a training day with a briefcase full of notes and a list of issues that need to be addressed across the spectrum of your standard operating procedures or working practices.
It was great to be able to return to work and congratulate the team for a job well done. Thus, enabling us to focus on what we are doing well and spend some time strategizing on how we can do things even better.
However, the team didn’t get away that easily. I returned, inspired, invigorated and armed with a clearer sense of direction and a renewed plan of action for the company.
So, although this year has been positive, next year is going to be a year for us to reach even higher.
Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
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