by Brian Lindsay | Sep 14, 2018 | Blog, Bona Fides, Brexit, MHRA
What do you want to do? Provide Information. When do you want to give it to us? Ummmm… OK, you might have been more definite in your final answer. But was it what the MHRA Inspector wanted to hear? Or see in your SOP’s? Particularly with regards to information on...
by John Finey | Aug 21, 2018 | Blog, Brexit, Training
I am sure plenty has been written and said about what I am sure many will see as an additional burden on wholesalers, this simple post is to help provide clarity about the scope of the regulations…
by Jackie (née Heneghan) Peck | Jun 29, 2018 | Blog, Bona Fides, Brexit, WDA(H)
The EMA( European Medicines Agency) set up a task force to prepare for the possible eventualities of the UK referendum. They had several areas of concern the main one being the potential disruption to the supply chain of medicines and the impact in public health. The...
by Jackie (née Heneghan) Peck | Jun 19, 2018 | Brexit, GDP/RP, MHRA, WDA(H)
How well do you know them? Ten Questions which you need to ask yourself about your QP (Qualified Person) Are they involved enough in the changes and decisions made in your organisation ? Do they report to the decision makers ? Can they easily communicate with the...
by John Finey | Jun 11, 2018 | Blog, Brexit, MHRA, NHS
There have been major regulatory changes within the Medical Device market, with more coming in the form of the Medical Device Regulations (MDR) which is in the process of being implemented at the moment. The main change that has affected the market over the last...
by Jackie (née Heneghan) Peck | Jun 1, 2018 | Analyisis, Behind the scenes, Blog, Brexit, Business, GDP/RP
Changes to the way data is held and processed are now in place since the adoption of GDPR legislation which came into force on the 25th May. Unless you have been living on a desert island somewhere, you could hardly have failed to notice this given the plethora of...
