Topic: Cell culture media suppliers: regulatory considerations for advanced therapies
Speaker: Marlin Frechette, Corporate Compliance & Quality Officer (CQO), FUJIFILM Irvine Scientific
Learn more about regulatory challenges and opportunities in media production for cell and gene therapy.
By choosing a media supplier that is prepared to partner with manufacturers through the raw materials qualification process and regional regulatory approvals, manufacturers can better address the challenges and opportunities on the road to bringing cell therapies to market.
What will you learn?
Regulatory requirements of different regions and how FUJIFILM Irvine Scientific (CA, USA) helps the customer understand:
- How long the regulatory approval process takes in different regions
- Unique raw material qualification processes
- The importance of safety and timelines for choosing a media supplier for clinical trials
- How the right media supplier helps with media costs
Who might this interest?
- Pharmaceutical companies
- Cell and gene therapy companies
- QC and regulatory bodies
- Process development teams
- Translational and clinical companies