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Medicines and Healthcare products Regulatory Agency
MHRA Inspectorate

Gail Francis

Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held various positions in monitoring, Project Management, and more recently in GCP Compliance and Training Management. Gail was promoted to Senior Inspector in October 2005 and accredited to perform Pharmacovigilance Inspections in November 2007. In June 2010 Gail was promoted to Expert Inspector, GCP.

Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons we have learned. In this final part, we explore the challenges ahead. Remote access to EHRs …

Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in …

Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the benefit of the UK …

Public Consultation on new Clinical Trials Legislation

Posted by: and , Posted on: - Categories: Events and symposia, Good clinical practice

The MHRA has launched an  8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit from the European Union, the Medicines and Medical Devices Act allows us the opportunity to update our current legislation in relation …

Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice

The ICH Management Committee is taking a unique step to provide a status update on the revisions to this guideline, via a public virtual conference on 18 and 19 May 2021. Register now.

MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice
Group photograph of MHRA GCP inspectors and US FDA

Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.

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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.

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