Gateway inspections are due to commence spring 2019 as the first stage of a new GDP inspection approach which will allow MHRA to increase its level of oversight whilst reducing the regulatory burden on those companies with a large number of sites which perform reduced or limited levels of GDP activity.
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!
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
An update on staff changes within the Inspectorate
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
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.
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.
The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.