EU Clinical Trial Regulation: Final Document No:536/2014
A 'heads up' on some GCP aspects by the RQA GCP Committee
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:
RQA Members: £20
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The RQA Member rate is also available as a concession to those working in relevant charities and academic institutions or for the National Health Service.