Webcast - EU Clinical Trial Regulation

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Non-Member: USD ($) 52.00

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Please note payment is required before access is given. However, if you need earlier access to the webcast please contact webcasts@therqa.com.

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