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Speaker Details

Christiane Niederlaender Vice President Technical CMC Parexel International London UK


Christiane has spent over 12 years in governmental medicines, tissue, cell and gene therapy regulation, 9 years of this at the UK medicines regulator MHRA. She was Unit Manager of the Biologicals Unit and a Senior Quality Assessor and UK delegate at the EMA committee for advanced therapies (CAT). She was 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 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