New QP Declaration for managing Expiry Dates of IMPs

In the recently published EMA Reflection paper on IVR/IWR systems, an additional QP Declaration is introduced for managing expiry dates. Overall the "Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials" seeks to provide guidance to Member States on what the expectations are on IVR/IWR systems and in particular on their use in expiry updating. In the case such a system is used to control expiry dates, a declaration by the Qualified Person (QP) is needed. This declaration should be part of both the Product Specification File (PSF) and Trial Master File. Annex 1 of the draft document shows what this declaration should look like.

In addition, the sponsor will need to notify the QP of the validation status of the IVR/IWR system (and any audit the sponsor has undertaken).

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.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)