Preparing the Development Safety Update Report

Event details

20th July 2011
Notified soon

About the event


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: Preparing the Development Safety Update Report:

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 online please visit;

Exhibitor information

The aim of SMi is Linking Business with Information through the delivery of high quality business to business information services. Our overriding advantage is our flexibility and ability to respond quickly to the requirements and needs of all our customers, ensuring that all SMi products are highly relevant, innovative and timely.

The SMi Group is a world leader in business to business information. Within the past year thousands of senior executives from blue chip companies benefited from SMi's highly targeted conferences, workshops and masterclasses.

As a market research based organisation, SMi takes pride in the quality of its programmes and documentation, ensuring that they are brought to the attention of the key decision makers in each industry sector in which it operates. We cultivate and maintain strong industry contacts to ensure that we are informed of all pending changes in government and regulatory policy, and we regard our relationships with speakers, delegates and subscribers as an investment for the future.