CIOMS VII - The Future

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Chapter: Pharmacovigilance: CIOMS Working Groups and their Contribution to Pharmacovigilance

The CIOMS VI working group proposed that there be a single Development Safety Update Report (DSUR) for submission to regulators on an annual basis, with a consistent format and content which had yet to be defined.


CIOMS VII - THE FUTURE

The CIOMS VI working group proposed that there be a single Development Safety Update Report (DSUR) for submission to regulators on an annual basis, with a consistent format and content which had yet to be defined. They strongly recommended that DSURs be based on an entire development programme and not per protocol. Consideration should be given to establishing a common international birth date which would be the date of first authorization to begin clinical trials anywhere in the world. The DCSI should be attached to the annual DSUR with an explana-tion of any changes since the last update, with any significant new safety information highlighted. Hence the CIOMS VII working group was formed to make recommendations on the format of the DSUR.

Progress on this and future CIOMS topics can be monitored on the CIOMS website (www.cioms.ch). The CIOMS VIII working group on data-mining had convened as this chapter went to press.

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