International differences in cellular starting material quality and regulatory requirements

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

International differences in cellular starting material quality and regulatory requirements

The webinar will focus on common challenges cell and gene therapy sponsors face when looking to treat a global patient population with allogeneic cell therapies that require sourcing of healthy donor starting material. Navigating international regulations for cellular starting material is complex, particularly as the rapid advancement of industry may precede regulatory guidance. When procuring cellular starting material and/or distributing cell and gene therapy product across international borders it is important to consider early on what country or regional requirements are at play and where they diverge.

Attendees will learn:

How donor compensation impacts the global marketability in cell & gene therapy
Apheresis centre assessment/qualification requirements for successful scalability
Understanding of anticipated EU regulatory changes and legislation on the horizon that will affect the industry
The differences in donor eligibility requirements between geographical regions