Online training: Managing and reporting serious breaches of the EU Clinical Trial Regulation
May 12, 2022
New Online Training from Brookwood Global, on demand.
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The EU Clinical Trial Regulation 2014 No. 536, as well as national regulations in other countries such as the UK, require that sponsors of clinical trials identify, manage and report certain serious breaches of the trial protocol, GCP and the Regulation. Now that the EU regulation is in force it is vital that everyone is aware of the fast and rigorous reporting requirement in order to comply with law and avoid inspection findings.
This 45 min online course summarises the requirements and content of the European Medicines Agency 2022 guideline relating to the management and reporting of serious breaches.