The CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass covers topics such as:
- 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
The CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass brings together:
- Quality Assurance Specialists
- CMC Regulatory Specialists
- CMC Project Managers
- Analytical / Pharmaceutical / Process Development Scientists and Managers
