12 March 2015

Implementation Working Groups (IWGs) have been set up for the ICH topics S3A, S9 and Q11 with a mandate to develop Question and Answer (Q&A) documents to clarify specific aspects of these Guidelines.

Input from Stakeholders is sought to collect questions and comments on potential issues identified with these three Guidelines since their implementation. Questions collected from stakeholders will be considered by the IWGs for inclusion in the Q&A documents currently under development.

More information can be found on all three consultations under the Open Consultations page.