Please note this course is now online please see the RSSL website for further details.
The area of Advanced Therapy Medicinal Products (ATMPs) has expanded rapidly over the past few years and continues to expand at a fast rate. There are now a small number of products fully licensed, plus many more already undergoing clinical trials plus numerous development projects in late phase development about to start clinical trials.
Although there is some guidance available, it has struggled to keep up with the rapid expansion of this area of product development in the Pharmaceutical arena. There is therefore a need for some practical GMP guidance for these products and sharing of experiences. These products do occupy a unique place as they are often used for critically ill patients. As companies move to needing authorised premises, they will be inspected by the Regulatory Authority and are likely to experience issues if they have not understood the applicable GMPs for ATMPs.
The course is suitable for those starting out working in this field and those who even if they have worked in this field for some time, have little or no understanding of the GMP expectations for this group of products. It could also be of benefit for trainee QPs who do not work in this field and have little understanding of the challenges involved.
By attending this course, you will :
•Understand what ATMPs are and why they are different from other pharmaceutical products
•Aware of the legislation and guidelines that pertain specifically to ATMPs
•Understand some of the practical GMP challenges that face those working in this field and how these are managed
•Feel more confident when interacting with colleagues in other disciplines
•Gain an awareness of a specialised area of development and manufacture
Course cost: £695 (+VAT)