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ICH GCP Update E6(R2) for Investigators & Sponsors Online Training
Product Code: ICH GCP Update for Investigators & Sponsors
Availability: In Stock
Availability: In Stock
Price:
£55.00
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A short online course based on the webinar on ICH GCP update for sponsors and investigators
Changes to ICH GCP brought about by the E6 R2 Addendum
by Professor David Hutchinson
November 2016 marked a milestone in GCP history when the proposed changes to the ICH GCP guidelines in addendum R2 were signed off as a Step 4 document.
This course will cover the changes the addendum brings and its impact for sponsors and investigators.
The course will include:
- Changes to GCP principles and definitions
- Greater requirement for trial oversight by investigators and sponsors
- Quality management system guidelines for sponsors
- Risk based approaches to trial monitoring
- Tighter requirements for changes to source data
- Modernisation relating to the use of electronic systems
- Trial Master File implications, including the revised definition of certified copy
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