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.
Good clinical practice
Following the February 2020 MHRA and FDA GCP symposium in London, our second joint paper is now available.
With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
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.
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
Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.
A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
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
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.