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.
This event covers an extensive range of topics and provides a comprehensive survey and in-depth analysis of the international regulatory perspectives, risk management, communication of safety information, risk management and practical challenges. The masterclass is headed by an expert who has in-depth knowledge and experience in regulatory and pharmacovigilance practices. She has worked at many top pharmaceutical companies and at Cancer Research UK, she was involved in setting up the pharmacovigilance department, which involved the implementation of the ArisG database, implementation of PV processes, as well as carrying out day to day PV activities from case processing, producing Annual Safety Reports and ongoing safety monitoring.
Gaining a deeper understanding into the development of the DSUR will enable firms to keep track of the future changes in the field of safety monitoring during the drug trial process. The course will provide the delegate knowledge of the objectives of the DSUR and what is expected of it, as well as helping them to overcome any other problems associated with it.
Benefits of attending SMi’s CPD accredited masterclass IED: Defeat the Device masterclass:
Upon completion of this Masterclass, through a combination of presentations and interactive discussion, you will:
- 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
For further information and the opportunity to register your place, please contact Patrick Bedwei on +44 (0) 20 7827 6151 or Email: pbedwei@smi-online.co.uk