Version 2.0 offers the following new
Version 2.0 has just been completed and has improved features to offer. All the guides
included on version 1.0 have been checked that they are up to date, and new drafts and new
documents have been included. New additions to the CD include ICH guides, Swiss IKS
guides, additions in the area of medical devices (D, EU, US FDA), warning letters,
presentation overheads (including from FDA, conference reports). Each participant in an
event organized by ECA in co-operation with Concept will receive a free copy.
Next to the main display, the table of contents is shown permanently in the left-hand part
of the window. This makes it even easier to switch back and forth between guidelines!
The new structure offers both greater clarity and, at the same time, more guides.
From a main directory arranged according to the document groupsFDA guides
Mutual Recognition Agreement
you can switch to the
Search option for your
As was the case with the previous version, you can still limit your search to within a
single document or have it include all pages. A selection list shows all the document
names. You can then click an individual document to select it. Thanks to the addition of
Warning Letters and FDA presentations you have not only the legal specifications but also
aids for their interpretation.
Full screen application
With the new full screen function you can call up the guidelines so that you can use them
in presentations by means of a beamer (e.g. in courses)