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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.

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.

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.

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

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man in office, working on desktop PC, smiling, arms in the air, in expression of joy.

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.