Preparing the Development Safety Update Report July 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.

SMi’s CPD accredited Masterclass, Preparing the Development Safety Update Report, provides the delegate with an in-depth analysis of the proposed internationally harmonised document; the Development Safety Update Report (DSUR), which is based on the Periodic Safety Update Report (PSUR) for marketed products.

Benefits of attending:

• Discuss the main ICH E2F guidelines
• Understand the objectives of the DRUR and what is expected
• Acquire knowledge of how a DSUR can be drawn up
• Prepare yourself for the challenges faced when drawing up a DSUR

Join industry professionals at SMi's CPD accredited Preparing the Development Safety Update Report event on 20th July 2011, Central London, UK. For further information and the opportunity to register, visit the website. Alternatively, please contact Patrick Bedwei via Email: [email protected] or Telephone: +44 (0) 20 7827 6161

Official Website: http://www.smi-online.co.uk/DSUR201124.asp