GOV.UK
Falsified Medicines Directive: Safety Features
Implementation of the FMD safety features in the UK
Compliance matters
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.
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.
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
eConsent
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
Sponsor Oversight- Part 2
Part two of this post provides two case studies from inspections where critical and major findings have been identified in regards to Organisation’s Oversight of Clinical Trials of IMP.
National and International GCP Symposia
On the 5 and 6 September, the GCP Inspectorate held their symposium and were joined by colleagues from the FDA, the Brazilian authority ANVISA and the Israeli Ministry of Health.