Summary
This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging ATMP topics. 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 for ATMPs.
Learning Objectives
- Understanding emerging Regulatory trends and Quality for ATMPs
- The criticality of Operational Excellence in ATMP manufacturing
- Advanced risk management for ATMPs
- Differences needed for autologous and allogeneic cell therapies
- Key starting materials and classifications
- Translate an effective CMC strategy into your regulatory submission for ATMPs
- Learn how to conduct a comparability study
- Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of ATMPs.
- Learn how to interact with the regulatory agencies; manage discussions and defend studies and strategies
- Avoid delays in clinical development and market approval
- How to deal with post-approval changes
Key Topics
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- Operational Excellence and alignment of business and CMC drivers
- Important and emerging CMC regulatory issues – problems and challenges
- CMC regulatory compliance for ATMPs – EMA & FDA
- Quality Risk Management and Quality by Design (QbD) principles for ATMPs
- Change management for ATMPs; FMEA de-risking, tech transfer and CMC activities
- Non-GMP materials, systems and control – making compliance and phase-appropriate acceptance
- Analytical, storage, stability, comparability and retention for ATMPs
- Comparability post Manufacturing process changes for ATMPs
- Handling & Supply – Product considerations, logistics, storage, supply, recall/destroy
- 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
- VC/investors in ATMPs
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 ATMPs
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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