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Webinar Overview
Regulatory requirements and robust analytical and process development are keys to success for CGT drug developers looking to bring a new therapy to market. However, when these critical components are not taken into consideration during early phases, it can often lead to roadblocks in clinical trials and GMP manufacturing. To meet GMP standards and commercialize a new cell or gene therapy, regulatory and testing milestones need to be integrated holistically, throughout the entire lifecycle of the drug product and even during post-market approval.
This webinar discusses the importance of considering regulatory compliance and optimizations during all phases of drug product development, starting with research and discovery through commercialization of your cell and gene therapy.
You’ll learn about:
- What regulatory considerations you should plan for throughout the entire lifecycle of your CGT drug product, even post market approval
- How early investment in analytics and process optimization improves quality control and manufacturing processes downstream
- What you need to know to successfully submit IND and BLA applications for future GMP manufacturing and commercialization and how to handle on-going regulatory approvals
Webinar Presenters
Felicia Irons
CDMO Regulatory Affairs & Compliance Lead
Charles River
Chad Andersen
Associate Director, Manufacturing Sciences and Technology
Charles River