Regulatory considerations should form an integral part of the translational strategy in bringing forward new candidate therapies. There are numerous factors in the regulatory space to be aware of, in particular with therapeutic stem cell products. Regulatory frameworks and relevant guidelines for human stem cell products have been established across various jurisdictions including Europe, the US and Australia.
Gain some clarity on the challenges of clinical translation in this space! This talk will offer a “Top Ten List” of key issues critical to the successful development of human stem cell based treatments.