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Good clinical practice

Global reflections on international inspection transformation: ICMRA remote inspections

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.

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'

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice
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.