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CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass
About
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 and 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
Profile Details
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
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