Event Date/Time: Jul 20, 2011
End Date/Time: Jul 20, 2011
The CIOMS VII Working Group is proposing an internationally harmonised document, the Development Safety Update Report (DSUR) to streamline the process by which drug trial safety is monitored, which should improve patient safety, especially during a time when the effectiveness of a treatment is uncertain. The reason behind this is due to the fact that even though regulatory authorities in Europe, the US, and other locations require annual submission of a Periodic Safety Update Report (PSUR); there are marked differences between formats, content and timings.
Join industry professionals at SMiâ€™s CPD accredited Masterclass, Preparing the Development Safety Update Report, and learn about a proposed internationally harmonised document; the Development Safety Update Report (DSUR). For further information and the opportunity to register, please visit the website.