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Webcast - EU Clinical Trial Regulation

RQA Member: USD ($) 26.00
Non-Member: USD ($) 53.00

Your Price: USD ($) 53.00

Webcast Information

The new EU Clinical Trials Regulation has been made final! Some have heralded it as the biggest change to Clinical Trials since the EU Clinical Trials Directive (2001/20/EC). The EU is dramatically changing the law regarding clinical trials. The RQA GCP Committee offers a 'heads-up' on some of the GCP aspects of the new Clinical Trials Regulation, from a clinical auditors point of view.

  • Looking for the possible future Inspection/Audit finding risks!
  • How protocols might have to change to avoid this
  • Where the dangers with Serious Breaches & USMs may be
  • Changes to the definition of GCP
  • Reporting third country inspections
  • Consent changes
  • Risk adaption and more.

The GMP and GPvP aspects are not covered.

This on-demand webcast is approximately 60 minutes in duration.

View a taster below

 

 


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Booklets

Comparison of Pharmacovigilance Regulations in Europe and Japan*
Good Clinical Practice Regulatory Authority Inspections
Management of the Training and Competency of Personnel in GxP and Research Environments

eLearning Products

Introduction to UK Clinical Trial Regulations elearning

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