Advanced Therapy Medicinal Products
About This Course
Advanced therapy medicinal products (ATMPs) are an emerging class of 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.
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 ATMP products, 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. We also provide an overview of the governing legislation and GMP requirements in force. Throughout the course, the typical challenges involved with the manufacturing, testing, QP certification and transportation of ATMPs is covered, including the challenges involved in certifying and releasing ATMPs with short shelf lives.
If you choose our virtual learning option, training is delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
Key Learning Objectives
On completion of this course, delegates will know and understand:
- Legislation and GMP requirements for ATMPs
- Different types of ATMPs
- Manufacture and testing of ATMPs
- ATMP batch record review
- ATMP logistics
- QP certification and release, including typical issues faced by a QP
- Auditing ATMP manufacturing and testing sites
Who Should Attend
- Those working with and implementing GMP for ATMPs
- Those involved in regulatory inspections and/or responsible for the regulatory aspects of 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.
Discounts offered to NHS staff, regulators and charities.
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