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.
Suitability
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.
Programme
The following topics are covered :
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.
Suitability
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.
Programme
The following topics are covered :
- What is an ATMP?
- Review of legislation guidelines available
- Principal challenges that exist during the manufacture and supply of these products
- Specific GMP issues that are relevant to ATMPs:
- Storage conditions and shelf life
- Documentation and traceability
- How to manage Out of Specification (OOS) events
