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Non-Member: USD ($) 53.00
Your Price: USD ($) 53.00
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