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Edinburgh CRF: Inspection Survival Guide: MHRA GCP Inspection

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Wellcome Trust Clinical Research Facility

Crewe Road South

Edinburgh

EH4 2XU

United Kingdom

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Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection

Course Description:

Statutory GCP inspections conducted by the Medicines and Healthcare products Regulatory Agency (MHRA), are an important part of the regulation of clinical trials in the UK. Anyone who sponsors, conducts or supports a clinical trial in humans involving an investigational medicinal product (CTIMP) or a medical device may find themselves face-to-face with an MHRA inspector. What an inspector will be looking for is evidence that trials have been conducted in compliance with applicable legislation and the principles of GCP. It is a daunting prospect for many, but an understanding of what to expect and how to prepare can help smooth the process and lead to a successful inspection outcome.

This half-day course will use presentations and workshops to provide an overview of the GCP inspection process from notification to closure, along with some handy hints and tips for surviving the experience relatively unscathed. It is aimed at anyone who may be involved in an MHRA GCP inspection.

Date: Tuesday 10th October 2017

Time: 0930 - 1230

Location: Seminar Room, Wellcome Trust Clinical Research Facility, Western General Hospital, Crewe Road South, Edinburgh, EH4 2XU

Course Fees:

Student Rate: (valid matriculation card required) £20

NHS/Academic Early Bird Rate: (before 29 August 2017) £30

NHS/Academic Rate after 29 August 2017: £40

Industry Rate: £40


To book a place, please email wtcrf.education@ed.ac.uk

For further information, please refer to the WTCRF website www.crts.org.uk

Facebook: WTCRFEducationProgramme

Twitter: @WTCRF_Education


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Date and Time

Location

Wellcome Trust Clinical Research Facility

Crewe Road South

Edinburgh

EH4 2XU

United Kingdom

View Map

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