May / June 2023

Insights

ISPE’s Emerging Leaders (EL) Steering Committee is taking time to get our foundation right so that we can help drive change and empower young pharmaceutical engineering professionals to pursue their dreams. Our vision and mission will serve as the pillar for how we engage with Emerging Leaders and students around the world, stay true to our goals, and adapt to regional requirements.

Features

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.

Insights

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?”

Features

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.