Articles by Herman & Erich Bozenhardt

1. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

   Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.