New circular 586 on the reporting of adverse events observed in clinical trials and submission of annual safety reports.

A new version of the "Detailed guidance on the collection, verification and presentation of adverse event / reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)" was published in June 2011. More information on the way these guidelines will be put into practice in Belgium is now published in circular 586.

The new version of the “Detailed guidance on the collection, verification and presentation of adverse event / reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)”, published in June 2011, contains a number of crucial changes, e.g. concerning the annual safety report and the electronic submission of SUSARs (Suspected Unexpected Serious Adverse Reactions).

For this reason, famhp has organised workshops with stakeholders and in February 2012 gave all stakeholders the opportunity of critically evaluating and commenting on the draft circular. The final version of circular 586, taking all comments into account, is now available.

Further questions may be sent to the following e-mail address: ct.rd@fagg-afmps.be

 

Last updated on
10/08/2012