Advanced Therapy Medicinal Products Training

This new Advanced Therapy Medicinal Products course builds on our introductory ATMP course, providing those who have spent some time working in the fast-paced and rapidly evolving area of ATMPs a more detailed look at crucial aspects of ATMP manufacture and validation. In this NSF ATMP course, we take you through the following areas:

• Seed lot and cell bank systems
• Some of the more complex analytical methods used throughout ATMP processes such as flow cytometry, qPCR and rapid sterility test methods
• How to deal with out-of-specification results during ATMP manufacture
• The risk-based approach for ATMPs
• The qualification of facilities and validation of ATMP processes
• The requirements for commercial import and export of ATMP products

This is a virtual training course delivered via a combination of an instructor-led virtual classroom and, prior to the course start, self-paced online learning that supplements the instructor-led session. Full details will be sent to you following registration.

On completion of this course, you will know and understand some of the key aspects of ATMPs in more detail, such as:

• Seed lot and cell bank systems
• Analytical techniques
• Out-of-specifications for ATMPs
• The risk-based approach
• Qualification and validation of ATMP premises and processes
• Import and export of ATMPs

There will be an opportunity for Q&A with the tutor and participants, so you can get your questions answered.

This ATMPs course is suitable for pharmaceutical professionals working in the ATMP arena.

Robert Smith - Robert has extensive experience in ATMP manufacturing and currently holds a role at the Cell and Gene Therapy Catapult. One of Robert’s key achievements was bringing the first ATMP drug/device combination to the global marketplace, working on both the clinical trials and the marketed product.