Good Clinical Practice & The EU Directive

When Mar 18, 2015 from 09:30 AM to 04:30 PM
Where Edinburgh
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This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or for those who have studied it more than two years ago.

 

It is presented very much as a practical introduction to the subject and consists of a mixture of a series of short lectures interspersed with practical activities, culminating in a monitoring workshop where delegates are asked to work in small groups and review trial paperwork in the role of the monitor. This activity allows a lot of the more abstract concepts that have been discussed throughout the day to be brought to life.

 

While the principles of GCP that are covered in the course are common to a wide range of different types of clinical research the course does focus on the drug trial specific legislation. However, it also tries to promote the ‘GCP-mindset’ needed to satisfy inspectors and auditors, and would therefore be useful for all clinical researchers.

 

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

 

Course Objectives:

Appreciate the need for regulation of clinical research

• Understand the UK legislative framework for Clinical

Trials of Investigational Medicinal Products (CTIMPs)

• Be familiar with the principles & conditions of Good

Clinical Practice (GCP)

• Understand the practicalities of demonstrating GCP

compliance

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