Christiane Niederlaender PhD

Christiane has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. In that capacity, she chaired and oversaw all formal scientific advice meetings and had in-depth involvement in Brexit preparedness. At the same time, Christiane was a Senior Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). She was a UK CAT Rapporteur responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline and quality lead for the gene therapy section of the new draft guideline for investigational ATMPs. She was a drafting group member in all other quality-related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector.