Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection About 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. Tutor James Gibson Cost *There are a limited number of fully-funded places available on this course for University of Edinburgh (UoE) and NHS Lothian (NHSL) staff and students. To be eligible for one of the funded places, you must provide an active UoE or NHSL email address. Terms and Conditions apply. *** Note - we offer a £20 discount on course fees if paying by debit/credit card - see below rates*** Category Rate (card) Rate (invoice/UoE internal transfer) Fully funded place (see eligibility above)* £0 £0 Student (matriculation details required) £40 £60 Academic/NHS £90 £110 Industry £180 £200 There is a cancellation date of 24/10/2024, if you cancel after this date you will still be charged. Book now: Inspection Survival Guide (07/11/2024) (link to external ePay website) Back to Education: Courses and events page Nov 07 2024 09.30 - 13.00 Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection This course will provide an overview of what to expect from the GCP inspection process in clinical research settings. Online (Zoom)
Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection About 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. Tutor James Gibson Cost *There are a limited number of fully-funded places available on this course for University of Edinburgh (UoE) and NHS Lothian (NHSL) staff and students. To be eligible for one of the funded places, you must provide an active UoE or NHSL email address. Terms and Conditions apply. *** Note - we offer a £20 discount on course fees if paying by debit/credit card - see below rates*** Category Rate (card) Rate (invoice/UoE internal transfer) Fully funded place (see eligibility above)* £0 £0 Student (matriculation details required) £40 £60 Academic/NHS £90 £110 Industry £180 £200 There is a cancellation date of 24/10/2024, if you cancel after this date you will still be charged. Book now: Inspection Survival Guide (07/11/2024) (link to external ePay website) Back to Education: Courses and events page Nov 07 2024 09.30 - 13.00 Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection This course will provide an overview of what to expect from the GCP inspection process in clinical research settings. Online (Zoom)
Nov 07 2024 09.30 - 13.00 Inspection Survival Guide: Being Prepared for an MHRA GCP Inspection This course will provide an overview of what to expect from the GCP inspection process in clinical research settings.
