With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in the development, unique challenges have emerged especially in the area of manufacturing and control. Leading biotech players are utilizing available regulatory pathways to accelerate the approval of ATMPs. However, the pathways to meeting CMC requirements are not as clearly defined. Novel approaches must be taken to ensure the identity, strength, quality, purity or potency of the product.
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns. Join us & achieve CMC readiness for your cell & gene therapy medicinal products.