Introduction to Advanced Therapy Medicinal Products Training
About This Course
Advanced therapy medicinal products (ATMPs) are innovative medicines whose properties make them very different from traditional pharmaceutical medicines. They bring new, complex challenges in terms of storage, handling and maintaining a chain of custody from raw material to patient.
In this NSF ATMP introduction training, we help you to navigate these challenges in complying with the stand-alone guidelines on Good Manufacturing Practice specific to ATMPs as published in November 2017.
This interactive course, led by a tutor who has extensive experience working with ATMPs, provides an overview of ATMPs including the different types and their manufacture, QC testing, logistical requirements, batch record review and the QP certification and release process. Throughout the course, we also discuss the typical challenges involved with ATMPs, bringing real-life experiences from our expert tutor.
This is a virtual ATMP manufacturing 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.
Key Learning Objectives
On completion of this course, you will know and understand:
- Legislation and GMP requirements for ATMPs
- The different types of ATMPs
- Manufacture and testing of ATMPs
- ATMP batch record review
- ATMP logistics
- QP certification and release, including typical issues a QP faces
- Auditing ATMP manufacturing and testing sites
Who Should Attend
- Those new to working with and implementing GMP for ATMPs
- Those moving from a different dosage form into 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.
The overall course was well constructed. A glossary would have been helpful of some of the more specific terms. Although my interest is tissue-engineered products, the course offered a good foundation for understanding the components and framework that would be used within tissue-engineered products, specifically for autologous and allogeneic cells.
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