Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. The week concluded with the second joint MHRA GCP and US Food and Drug Administration (FDA) event following that hosted by the FDA in the USA in October 2018, and the first one hosted by the MHRA in the UK.
Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. This included individual events from the GPvP, GCP and Laboratories Inspectorates where a host of regulators and delegates from across the globe came together. Second on the week-long agenda was the laboratories symposium, running on the 12th February and attended by 315 delegates.
During the Covid-19 pandemic you may need to adjust how you operate. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles.
Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.
The Good Pharmacovigilance Practice (GPvP) Symposium 2020, held on 11 February in London and attended by 380 delegates, launched the weeklong series of events led by the Inspectorate as part of the MHRA Good Practice Symposia week.
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019
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.
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.
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.
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.
