May / June 2023


The success of the biopharmaceutical industry and the expansion of manufacturing facilities, of both existing companies and newcomers, has put a strain on the number of temporary and permanent skilled workers needed to fill many positions in the Triangle.


It is hard to believe that by the time this column is published, my term as Chair will be half over. We’ve accomplished much, and I’m left wondering, “Where has the year gone?”


When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021.