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Registration open for the MHRA Good Clinical Practice (GCP) Non-Commercial Symposium 2011

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Registration open for the MHRA Good Clinical Practice (GCP) Non-Commercial Symposium 2011

The MHRA has now opened registration for it’s Good Clinical Practice (GCP) Non-Commercial Symposium 2011. The event will cover the new Risk Adapted Approach for Clinical Trial Investigational Medicinal Products (CTIMPs) and the new Development Safety Update Reports (DSURs) requirements.

In detail the event will cover:

  • All you will need to know about Development Safety Update Reports (DSURs) that come into force on the 1 September 2011
  • Key differences between Annual Safety Reports(ASRs) and DSURs, including data that may be difficult for non-commercial sponsors to obtain and how this should be handled
  • Discussion on the International Conference on Harmonisation (ICH) DSUR guideline E2F and associated non-commercial example DSUR
  • MHRA expectations for submission formats
  • Update and current progress on the risk adapted approach for clinical trials
  • Implications of the risk adapted approach for GCP and inspections
  • Data management, statistics and reporting of data from a research and development perspective
  • Data management, statistics and reporting from an investigators perspective

This is a one day event.  Fees are as follows:

£240 – Early-bird rate (book by 21 September for this rate)
£295 – Standard rate

source and more information can be found:

http://www.mhra.gov.uk/ConferencesLearningCentre/Conferences/CON126068?tabName=Why%20attend%3f