RSSL: Good Manufacturing Practice for ATMPS
Event Start Date: Thu, 02 Apr 2020 00:00:00 GMT
Event End Date: Thu, 02 Apr 2020 23:59:00 GMT
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.
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