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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.

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

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

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

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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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