Skip to main content

Paula Walker

Paula Walker is currently the MHRA GCP Inspectorate Operations Manager and a Senior GCP inspector, having worked for the Agency since April 2009. Paula has a Masters in Biotechnological Law & Ethics, a Post-Graduate Diploma in Clinical Trials and a BSc in Biomedical Science.

Prior to joining the Agency Paula worked in research governance and clinical trials regulation in the non-commercial sector. She started in the NHS working in research and development in a number of roles including ethics management and training, and subsequently worked as a research manager in the higher education sector. Following this she moved back into clinical research and trials regulation working in a number of universities, providing operational and regulatory support for sponsored trials. Paula has been a GCP inspector since 2009 and an MHRA Inspectorate Operations Manager since 2013.

Pharmacovigilance Inspection Metrics April 2020 to March 2021

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
analysing data with a magnifying glass

The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published on GOV.UK. We hope that the report is informative and useful for considering compliance and improvements within …

Global reflections on international inspection transformation: ICMRA remote inspections

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.

Inspectors grounded - a year of innovation

The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health

Round Table: The impact of Electronic Health Records on UK Clinical Trials

An ECG and various health images

On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). This post details how to register your attendance for this event.