Addressing the skills gap in ATMP/CGT manufacturing (A CellCAN/CCRM partnership)

Adopting a Life-Cycle Approach to Cell & Gene Therapy Manufacturing

Adopting a Life-Cycle Approach to Cell & Gene Therapy Manufacturing

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Available in Summer 2022

Pre-market drug submissions are just one component of regulatory affairs. Regulators also require ongoing reporting and submissions, including site licensing, change management, and deviation assessments.  This course will introduce regulatory concepts beyond drug submissions, touching on topics such as risk assessments, investigations, corrective and preventative actions, and product comparability.

Learning objectives: 

  • Encourage you to plan beyond first-in-human studies
  • Help you strategically plan for inevitable manufacturing changes
  • Gain basic understanding of Quality by Design principles and tools