BioInsights - International differences in cellular starting material quality and regulatory requirements
Aug
30
2022
Upcoming webinar

International differences in cellular starting material quality and regulatory requirements

Tuesday August 30th 2022 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

Beth Kuker

Manager, Regulatory Affairs, Be The Match BioTherapies

Petr Machalik

International Collection Network Manager, Be The Match BioTherapies



22
Days

SPEAKERS

Beth Kuker
Beth Kuker
Manager, Regulatory Affairs Be The Match BioTherapies
Petr Machalik
Petr Machalik
International Collection Network Manager, Be The Match BioTherapies

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