ICH GCP update for sponsors and investigators

ICH GCP update for sponsors and investigators
Product Code: ICH GCP update for sponsors and investigators
Price: £30.00

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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 marks a milestone in GCP history when the proposed changes to the ICH GCP guidelines in addendum R2 are 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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