Cell & Gene Therapy Insights Webinar

Virtual | Jan 13, 2021–Jan 13, 2021


Topic: Raw Materials of Biological Origin: Navigating Regulatory Requirements for Cell Therapies
Date: Wednesday, January 13, 2021
Time: 8:00 AM PST

Presented by:
Dominic Clarke
Global Head of Cell Therapy
HemaCare

Marlin Frechette
Chief Quality & Compliance Officer
FUJIFILM Irvine Scientific

This webinar will explore the specific regulatory requirements of different regions (including analysis of the amount of time the regulatory approval process takes in each case), and improve attendees’ understanding of the critical quality attributes (CQAs) of cell therapy raw and starting materials. The importance of a risk-based approach to raw material sourcing will be emphasized, as will the importance of harmonization and standardization of processes and protocols in cell therapy.

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