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F43 Implementing the updates to ICH-GCP - E6[R2]


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Who should attend?

This course is NOT suitable for individuals without prior knowledge of GCP or looking for a GCP refresher as it only addresses the key change areas.

Details

ICH has issued a substantial change to the Good Clinical Practice Guideline, reflecting the substantial changes to the clinical trial landscape since 1997.  In this course we will examine the changes in detail and discuss how these may impact day to day practice.

There have been increases in globalisation, study complexity, and technological capabilities; resulting in a need for innovative approaches to clinical trial design, management, oversight, conduct, documentation.  This key update recognises that while the original guideline did allow for innovative approaches, these were sometimes poorly implemented emphasising less important aspects of trials (e.g., focusing on the completeness and accuracy of every piece of data) at the expense of critical aspects (e.g., carefully managing risks to the integrity of key outcome data).

 

• Summary of changes to the guideline
• Oversight
• Risk Based Approaches
• Data Integrity
• Electronic Systems

Prices

One Day Course ICR Member - 450GBP (credit card 463.50GBP) ICR Member (Academic/Freelance) - 350GBP (credit card 360.50GBP) Guest - 550GBP (credit card 566.50GBP)

Contact

Jo Hall
office@icr-global.org

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