EMA Reflection paper on IVR/IWR systems

Over the last 15 years there has been an increasing utilisation of interactive voice response systems (IVRS) utilising telephones. Such systems have been developed further into interactive web based systems (IWRS) utilising the internet. These systems were developed initially to optimise drug availability at sites. However, this has expanded into other areas such as dose titration, unblinding and expiry date updating. This of course may, if not handled appropriately, pose an increased risk to the patient and so IVRS/IWRS is of increasing interest to National Competent Authorities (NCAs).

This draft paper seeks to provide guidance to Member States on what the expectations are of these systems and in particular their use in expiry updating.

The end of consultation (deadline for comments) is 15 February 2012. Comments should be provided using this template. The completed comments form should be sent to gcp@ema.europa.eu.