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Good clinical practice

Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision

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The ICH Management Committee is taking a unique step to provide a status update on the revisions to this guideline, via a public virtual conference on 18 and 19 May 2021. Register now.

Inspectors grounded - a year of innovation

The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health

MHRA planning for return to on-site Good Practice (GxP) inspections

Virus Particles

On 23rd March 2020 MHRA I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply and delivery of healthcare in support of the COVID-19 pandemic

MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'

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Group photograph of MHRA GCP inspectors and US FDA

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.

Good Clinical Practice Symposium 2020

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Good Clinical Practice Symposium 2020

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.

MHRA Good Practice (GxP) inspections during the COVID19 outbreak

Virus particle

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.