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Overview
This Inspection Survival Guide - Being prepared for an MHRA GCP inspection course offered by The University of Edinburgh is designed for academic, public sector and charity workers and they are offering it at a discounted price for people working in those sectors
This half-day course gives an overview of the Good Clinical Practice (GCP) inspection process in clinical research settings.
key facts
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 course will be delivered online via MS Teams.
Programme Structure
What you'll learn:
- Be familiar with the MHRA GCP inspection process, from notification to closure
- Know what to consider when planning and preparing for a GCP inspection
- Understand good inspection interview technique and how to answer questions
- Understand how to structure an inspection response and implement effective CAPA
Key information
Duration
- Part-time
- 1 days
Start dates & application deadlines
- StartingApply anytime.
Language
English
Delivered
Online
Campus Location
- Edinburgh, United Kingdom
Disciplines
Health Sciences View 283 other Short Courses in Health Sciences in United KingdomWhat students do after studying
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Academic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
We are not aware of any English requirements for this programme.
Other requirements
General requirements
- There are no specific entry requirements for this course.
- To obtain additional information about the programme, we kindly suggest that you visit the programme website, where you can find further details and relevant resources.
Tuition Fees
Tuition fees are shown in and the most likely applicable fee is shown based on your nationality.
-
International Applies to you
Applies to youNon-residents90 GBP / full≈ 90 GBP / full -
Domestic Applies to you
Applies to youCitizens or residents90 GBP / full≈ 90 GBP / full
Funding
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