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.

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

Paula Walker, Gail Francis and Jennifer Martin, 8 October 2019 - Compliance matters, Events and symposia, Good clinical practice

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.

How to manage safety reporting in a blinded trial

Gail Francis and Kirsty Wydenbach, 9 April 2019 - Compliance matters, Good clinical practice

Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs

Short format Development Safety Update Report (DSUR) for Type A trials

Gail Francis and Rosalind Polley, 13 March 2019 - Compliance matters, Good clinical practice

Not all trials are the same in terms of risk. To support UK sponsors of clinical trials, a substantially simpler and shorter form may be submitted in lieu of a full DSUR, giving a significant time saving.

Upcoming GCP stakeholder engagement meeting

Gail Francis, 21 September 2017 - Compliance matters, Good clinical practice

The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.

Inspecting clinical trials - The trial master file

Gail Francis, 30 July 2015 - Compliance matters, Good clinical practice

The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights …

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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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Recent posts

• Public Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
• DSUR Submissions and Fees are Changing from 1 June 2024
• Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium
• Pilot GMP Single Inspection Program
• MHRA Pharmacovigilance Symposium 2024