A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
Hayley joined the MHRA in August 2015 as a GCP Inspector. Prior to joining the MHRA Hayley had worked in GCP Quality Assurance and Quality Systems since 2008 within commercial early phase clinical research organisations. Hayley has a BSc Hons in Pharmacology from the University of Manchester.
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.
In October 2015 a number of MHRA GCP Inspectors attended the GCP Inspectors Working Group Workshop hosted by the European Medicines Agency (EMA) in London. This is an annual training event originally held for EU Good Clinical Practice (GCP) Inspectors that …
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