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The new EU Clinical Trial Regulation 536/2014 represents the greatest regulatory change to clinical trials in Europe, since 2001, when the first EU Directive was finalised. Clinical Investigators perform the most critical role in clinical research trials and hence are often the focus of Regulatory GCP Inspections. It therefore follows that Clinical Investigators must be able to demonstrate readiness for these important changes.
This RQA webcast introduces the GCP aspects of the new EU Clinical Trial Regulation 536/2014, and specifically how they impact Clinical Investigators and their site staff.
This webcast is for Clinical Investigators, at investigator sites throughout Europe, who work on sponsored clinical trials (commercial and non-commercial), on Investigational Medicinal Products. It is not suitable for Investigator Initiated Trials (IIT) where the investigator may also take on sponsor responsibilities. To get the most out of this webcast, participants should already be GCP trained and have knowledge of ICH GCP and the EU clinical trials directives.
Following the webcast the participant will be emailed a certificate of completion.
This on-demand webcast is approximately 45 minutes in duration.