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======================================================================================== Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection ======================================================================================== Wednesday 10 October 2018 (09:30-13:00 ) Location: Seminar Room, Wellcome Trust Clinical Research Facility, Western General Hospital, Edinburgh Trainer: James Gibson Course Fee: • Student Rate: £24 (with a valid matriculation card) • NHS/Uni Early Bird Rate paid before 29 August 2018: £36 • NHS/Uni Rate paid after 29 August 2018: £48 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. To book a place, please email the WTCRF Education Team at [log in to unmask]<mailto:[log in to unmask]> or register online using the following link<https://www.crts.org.uk/Content.aspx?dbid=crts&layout=CRTS+Master&theme=CRTS&areaid=118&name=Course&iid=3957&type=Content&oid=Screen&uirefid=1272> ======================================================================================== ‘There’s an SOP for That’: A Practical Guide to Standard Operating Procedures ======================================================================================== Tuesday 13 November 2018 (09:30-12.30) Location: Seminar Room, Wellcome Trust Clinical Research Facility, Western General Hospital, Edinburgh Trainer: James Gibson Course Fee: • Student Rate: £24 (with a valid matriculation card) • NHS/Uni Early Bird Rate paid before 02 October 2018: £36 • NHS/Uni Rate paid after 02 October 2018: £48 Standard Operating Procedures (SOPs) are key tools in any quality management system. In clinical research, they can help to protect the safety of participants and the integrity of data by ensuring that essential processes are performed correctly and consistently every time. Well written and managed SOPs can enhance the quality, efficiency and credibility of a research project. However, get them wrong and they can quickly become more of a hindrance than a help! This half-day course is designed for anyone who is involved in writing or managing SOPs in a clinical research setting. In addition to short presentations, the course includes a significant practical component, offering attendees the chance to practice and hone their SOP writing skills. To book a place, please email the WTCRF Education Team at [log in to unmask]<mailto:[log in to unmask]> or register online using the following link<https://www.crts.org.uk/Content.aspx?dbid=crts&layout=CRTS+Master&theme=CRTS&areaid=118&name=Course&iid=4321&type=Content&oid=Screen&uirefid=1272> Education Core | Wellcome Trust Clinical Research Facility | The University of Edinburgh | Western General Hospital | Crewe Road South | Edinburgh | EH4 2XU The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336. You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask]<mailto:[log in to unmask]>, leaving the subject line blank. You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.