An Inspector Calls: Preparing for an MHRA GCP Inspection

When Sep 23, 2015 from 09:30 AM to 12:30 PM
Where Edinburgh
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The highly regulated world we operate in as clinical researcher’s means we must be ready for audit and inspection at any time. The Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority in the UK that oversees the licensing of new drugs and the conduct of clinical trials of both drugs and devices. As part of their statutory remit they conduct compulsory inspections of sites and institutions on a regular basis. One important aspect of these inspections is ensuring that a study is being conducted in compliance with the legislation and in accordance with the principles of GCP.

 

Thus, being prepared for a GCP inspection is an essential part of good research conduct. In this workshop, Allan Gaw, will take delegates through the elements of a GCP inspection, and, using a mixture of short lecture presentations and practical activities, he will help them develop an effective strategy for preparing for such a visit.

 

After this workshop each delegate should:

• Understand the role of the MHRA in ensuring public safety

• Be aware of the different kinds of MHRA inspections

• Understand how a GCP inspection will be initiated and conducted

• Be aware of the common findings at such inspections

• Have a strategy for preparing for a GCP inspection

 

What previous participants have said about the course:

“Very engaging trainer—easy to listen to”

“Excellent course”

“An enjoyable course”

“I would recommend the course”

 

More information about this event…