Session Details

Q&O Session 3: Regulatory CMC Considerations of ATMPs
Friday, May 29, 2020 10:45 AM - 12:15 PM
Quality & Operations
The Q&O track regulatory session will address the hot CMC topics of 2020. For many ATMP products identification of critical quality attributes (CQAs) that can predict clinical outcome is not easy, especially due to inherent variability of the starting materials. Product characterization and selection of most useful assays will be discussed in this session, as well as the GMP constraints across the US and the EU. In the panel discussion regulatory experts from US, EU and Japan will address the CMC readiness of companies and regulatory authorities in the context of the expedited regulatory programs of ATMPs.