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.
In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.
Why it's a good idea for the UK to be part of the OECD MAD framework
Implementation of the FMD safety features in the UK
Applying risk-adapted approaches – how this worked for a researcher in neonatal trials.
The MHRA Laboratories Symposium will be held on 13 March 2019 at the Novotel in London. Also ... we have recently changed the contact email address for the laboratories inspection group from glp@mhra.gov.uk to gxplabs@mhra.gov.uk
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.
All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.
The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK
Dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Good quality data and sound procedures are vital to ensure the safety of all trial subjects.
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
