Requirements for Governance and Preparation of Gene Therapy
Good Clinical Practice specific to Advanced Therapy Medicinal Products
Regulatory requirements for export of ATMP starting materials
Out of Specification Advanced Therapy Medicinal Products
Handling dry ice and vapour phase nitrogen shippers
In-vivo (virus based) Gene Therapy Medicinal Products
Ex-vivo (Cell Based) Gene Therapy Medicinal Products
Somatic Cell Therapy Medicinal Products
Tissue Engineered Products