Duration: 55 mins

Speakers:

• Andrea Zobel, PhD, Senior Director, Personalized Supply Chain, World Courier
• Kelly Frend, Personalized Supply Chain Manager, World Courier
• Graham Clarke, Head of QA & QP at Cell and Gene Therapy Catapult
  
  

Overview:

The number of cell and gene therapies entering clinical trials is growing at an increased rate. Having a strong supply chain is essential to both patient safety and product success and it demands flawless execution in everything from the transport route selected, to how the packaging is evaluated, validated and used to maintain product integrity across all conditions.

On March 2nd, 2022, World Courier and Catapult industry experts talked about the regulatory framework and the role of the European Qualified Person in cell and gene therapy manufacturing and distribution. 

The session was followed by a live Q&A, where they discussed the solutions that are vital for overcoming the challenges faced in a highly regulated environment.

Key learnings

• The importance of international regulations and how to be GDP and ISO 21973 compliant
• European ATMP and ATIMP regulations
• Technical solutions to fulfill the requirements (tracking requirements, cryogenic supply chain, intermediate storage during import, etc)
• Qualified Person tasks and responsibilities
• Differences between medicinal products and advanced therapy medicinal products quality control and release processes
• How to manage time, temperature and process challenges (e.g. labelling of cryogenic products, quality tests and retention samples of autologous therapies, out of specification results after administration)