CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

Topics

• Overview of specific CMC and GMP relationships in case of expedited programs
• Relationships with Regulatory Authorities on CMC data and the Manufacturing Readiness Plan
• Prime, Conditional Approval, Accelerated Assessment, Exceptional Circumstances
• Stability Data Considerations & Pharmaceutical Quality System Alignment

Who should Attend

• Quality Assurance Specialists
• CMC Regulatory Specialists
• CMC Project Managers
• Analytical / Pharmaceutical / Process Development Scientists and Managers