21st July 2021
Any European Marketing Authorisation Holders (MAH) who choose to establish a QPPV (Qualified Person for Pharmacovigilance) who resides and operates in the EU/EEA must also nominate […]
23rd October 2020
As at 23 October 2020, the situation regarding a Deal or No Deal Brexit is extremely fluid. As such, rather than bombard you with our guesses […]
3rd September 2020
On Monday 1 September 2020, the MHRA released an update to the guidance on pharmacovigilance post-transitional period and I am sure we all heard the emails […]
19th March 2020
Good Clinical Practice (GCP) inspections and how they are conducted has evolved massively over the years and has had to, due to the increased complexity of […]
13th March 2020
As we are all now terribly aware, COVID-19 is proving to be a challenge across all areas of industry. Recently, the MHRA have announced on their […]
17th February 2020
The UK’s medicines cost-effectiveness agency NICE has agreed to look again at its decision to turn down NHS funding of Novartis’ Aimovig for migraine prevention after […]
12th February 2020
7th February 2020
There has been and still is a huge amount of confusion regarding the requirements for establishing a UK QPPV following the UK’s exit from Europe on […]