CMC Regulatory Requirements for Biosimilars | Symmetric EventsCMC Regulatory Requirements for Biosimilars
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TRAINING TIMES
- TBDVienna
- TBDLondon
- TBDNew York
- TBDLos Angeles
LEARNING OBJECTIVES
Understanding emerging trends in the field of Biosimilars
Understanding emerging trends in the field of Biosimilars
The Regulatory frameworks and expectations relevant for Biosimilars
The Regulatory frameworks and expectations relevant for Biosimilars
Differences in various stages – R&D, Process Development and Manufacturing
Differences in various stages – R&D, Process Development and Manufacturing
Key starting materials, classifications, references and standards
Key starting materials, classifications, references and standards
Understanding risk management
Understanding risk management
Quality by Design (QbD) and how to implement best practices
Quality by Design (QbD) and how to implement best practices
CMC strategies and control practices
CMC strategies and control practices
Criticality of analytical quality
Criticality of analytical quality
Important facets of comparability
Important facets of comparability
Extrapolation guidelines
Extrapolation guidelines
Clarified interchangeability and further Biosimilar guidances for designation
Clarified interchangeability and further Biosimilar guidances for designation
How to deal with changes
How to deal with changes
KEY TOPICS
Legal & Regulatory Framework Scientific foundations of Biosimilar Development Regulatory pathways and submissions
Biologics Regulations for Biosimilars Comparability, extrapolation & switching, Interchangeability Analytical Quality considerations References, Regulatory assistance and reliances Change management: FMEA de-risking, tech transfer & CMC activities Case studies – challenges & solutions (successful and unsuccessful cases) Non-clinical and clinical studies CMC assays & Control Strategy 
