17 February 2017

The ICH E11(R1) draft Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process and is currently under public consultation. This Addendum was proposed to address new scientific and technical knowledge advances in pediatric drug development. A training presentation has been developed by the Expert Working Group.

Please find on the E11(R1) page a presentation available for download