It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.
The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients.
Following on from our previous post, further guidance has been published on our MHRA website in relation to Managing Clinical Trials and Clinical Trial Applications.
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
GCP inspections and how they are conducted has evolved over the years due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology.
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