GOV.UK
Falsified Medicines Directive: Safety Features
Implementation of the FMD safety features in the UK
Risk-adapted Approach: Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care - Part 1
Applying risk-adapted approaches – how this worked for a researcher in neonatal trials.
MHRA Laboratories Symposium 2019 ... plus GXP mailbox update
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
It pays to be compliant!
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.
Is it really a First in Human trial? Categorising and assessing the risks correctly
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.
Pharmacovigilance Inspection Metrics April 2017 to March 2018
The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK
Dose Escalation - is it GCP compliant?
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.
Making GCP Training Relevant and Applicable: It’s Not Just for Clinical Staff
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
Cross-contamination control and Health Based Exposure Limits (HBEL) Q&As
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
MHRA Inspectorate staff changes
An update on staff changes within the Inspectorate