Summary
This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging biological products. You will learn how to develop good CMC-compliant regulatory practices and avoid market-approval delays. This course is suitable for all those involved in CMC development and implementation.
Learning Objectives
- Translate an effective biologics CMC strategy into an effective regulatory submission
- Learn how to conduct a comparability study
- Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of biologic products.
- Learn how to interact with the regulatory agencies; manage discussions and defend studies
- Avoid delays in clinical development and market approval
- How to deal with post-approval changes
Key Topics
- CMC regulatory compliance for biologics – EMA & FDA
- Quality by Design (QbD) principles for biologics manufacturing
- Change management for biologics
- Analytical, stability and biological comparability studies
- Biological comparability post Manufacturing process changes
- Interacting with regulatory authorities
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
- Revisit recorded sessions for 7 days
- 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 Compliance for Biological Drug Products
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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