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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.

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.