GOV.UK
Process Licensing Update
The purpose of this post is to give an update on a change to how we are issuing our licences and certificates due to the coronavirus pandemic; and a reminder to keep your contact details up to date.
Compliance matters
Advice for Good Laboratory Practice facilities in relation to coronavirus (COVID-19)
It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.
MHRA Good Practice (GxP) inspections during the COVID19 outbreak
The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients.
MHRA Guidance on Coronavirus
Following on from our previous post, further guidance has been published on our MHRA website in relation to Managing Clinical Trials and Clinical Trial Applications.
Advice for Management of Clinical trials in relation to Coronavirus
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
GCP Inspections: Expectations and the dos and don’ts for hosting
GCP inspections and how they are conducted has evolved over the years due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology.
Maintaining control: Remote working and QP certification
In the modern world it is increasingly common to see flexible, part-time or home working arrangements. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.
The 2019 GMDP Symposium
The MHRA GMDP Symposium took place on 11 to 14 November 2019 in London and 26 to 27 November 2019 in Glasgow. The theme of the GMP event was ‘Control Strategies’, whilst the GDP days focussed on supply chain challenges faced by wholesalers.
MHRA Good Practice Symposia week (11 to 14 February 2020)
Between 11 to 14 February 2020, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. The week will include individual events from GPvP, GCP and GLP Inspectorates
MHRA GCP Non-Commercial Symposium 2019
The annual GCP Symposium was held by the MHRA on 11 September 2019 in Manchester. The symposium focused on non-commercial organisations (Trusts/Health Boards/University sponsors, Charities and investigator sites) and covered a variety of topics.