Summary
The objective of this course is to provide you with tools for navigating the regulatory landscape, developing a robust CMC strategy and understanding the manufacturing process. Combined with a sound understanding of these complex melecules, including the mechanisms of action and pharmacology, you will be able to submit good filings and avoid market delays.
Learning Objectives
- Understand the regulatory frameworks governing ADCs
- Develop effective CMC strategies to ensure product quality and compliance
- Implement robust quality control and assurance measures throughout the development lifecycle
- Gain insights into manufacturing processes specific to ADCs
- Understand analytical methods for characterisation and stability assessment
- Navigate Change & lifecycle management effectively
- Mitigate risks and maintain compliance with regulatory requirements
- Understand emerging trends in ADCs
- Understand the importance of formulation risk management
- Learn the latest trend in Quality by Design (QbD) and how to implement best practices for ADCs
- Learn how to conduct a comparability study for ADCs
- Avoid delays in clinical development and market approval
Key Topics
- Regulatory Frameworks and Guidelines
- CMC Strategies for ADCs
- Quality Control and Assurance
- Manufacturing Processes
- Analytical Methods and Characterisation
- Stability Studies and Comparability Assessments
- Post-Approval Changes and Lifecycle Management
- Risk Management and Compliance
Who should attend?
This course is suitable for all those involved in:
- Quality
- CMC
- Regulatory Affairs
- Manufacturing/ MSAT
- Process Development
- 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.
Manufactuing of Antibody Drug Conjugates
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