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Non-Member: USD ($) 51.00
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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.
The GMP and GPvP aspects are not covered.
This on-demand webcast is approximately 60 minutes in duration.
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