Summary
This 3-day CMC training is designed to keep you up to date on emerging strategies and practices relevant to the Quality Requirements and Regulatory landscape for Biosimilars. You will learn how to develop best Biosimilar development practices which are relevant for intended uses and regulatory compliance to avoid costly project and market-approval delays. This course is suitable for all those involved in Biosimilar workflows, where training is especially desired on Quality
Learning Objectives
- Understanding emerging trends in the field of Biosimilars
- The Regulatory frameworks and expectations relevant for Biosimilars
- Differences in various stages – R&D, Process Development and Manufacturing
- Key starting materials, classifications, references and standards
- Understanding risk management
- Quality by Design (QbD) and how to implement best practices
- CMC strategies and control practices
- Criticality of analytical quality
- Important facets of comparability
- Extrapolation guidelines
- Clarified interchangeability and further Biosimilar guidances for designation
- How to deal with changes
Key Topics
- Legal & Regulatory Framework
- Scientific foundations of Biosimilar Development
- QbD for Biosimilars
- 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
Who should attend?
- QA/QC Managers
- Regulatory Affairs Managers
- CMC Managers/ Heads
- Analytical Scientists
- Development Scientists
- Manufacturing
- Process Development
- Product Stability Managers
- R&D Scientists
Past delegate profile
- CMC Project Manager, Mithra Pharmaceuticals
- Regulatory Affairs Project Manager, Lonza
- Senior Manager, European Central Regulatory Affairs, Mylan/Viatris
- Head of Manufacturing, Biotalys
- Head R&D Development Unit, GSK Vaccines
- Senior Manager, Regulatory CMC, Takeda Manufacturing
- Associate Manager Regulatory Information Management, Regeneron
- CMC Lead, Uniqure
- Regulatory Affairs Specialist, Novavax
- Associate LI, Regulatory Affairs CMC, Gilead Sciences
- QC Manager, Bayer
- Regulatory Affairs Specialist, CSL Behring
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Digital and LinkedIn certificates
Trainers
Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.
CMC Regulatory Requirements for Biosimilars
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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