Annex 1: Manufacture of Sterile Products | Eudralex Vol 4 Annex 1 draft has been released for comments ending May 2020. Share Industry comments supported by ISPE. as recognized organization for collecting comments. The session aims to introduce comments submitted to European Commission by ISPE, discussion on these topics. Regulators from around the world have been invited to discuss these comments or having regulators giving presentations on the draft and comments.
Division Director, Office of Product Quality,