20 February 2017

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period. A training presentation has also been developed by the Expert Working Group.

Please find on the Q11 Q&As page the presentation for download.