Christiane Niederlaender

Director, AMBR-Consulting formerly MHRA Senior Quality Assessor for Biologics and CAT member
AMBR Consulting Ltd
Maria Lluch Senar
Christiane has spent 12+ years in medicines, tissue, cell and gene therapy regulation, last with the MHRA, where she worked until August 2019 assessing all groups of biological medicines. Christiane was the UK representative at the EMA committee for advanced therapies (CAT) and the Rapporteur/ Co-Rapporteur/ CMC assessor for several ATMPs. She acted as the Rapporteur for the EMA gene therapy guideline and was drafting group member for many other CAT guidelines. Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European Tissues and Cells Directive as an assessor and inspector. She has a Ph.D. and research background in cell-signalling, cancer and stem cells and obtained a law degree in 2005. Christiane has set up her own consultancy company in September 2019.

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