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Christiane Niederlaender
Director, AMBR-Consulting; at Former Senior Quality Assessor for Biologics, Medicines and Healthcare ProductsRegulatory Agency (MHRA); Former Member, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA)

Profile

Dr Christiane Niederlaender, Director, AMBR Consulting

Christiane has spent 12+ years in medicines, tissue, cell and gene therapy regulation. For the last 8 years she has worked at the MHRA, the UK’s medicine regulator, where she has assessed all classes of biological medicines at both UK and EU level and acted as the UK representative at the European Medicines Agency’s (EMA) committee for advanced therapies (CAT). Christiane was the Rapporteur/ Co-Rapporteur for several advanced therapy medicinal products (ATMPs) and many other biological product applications, including biosimilars. She acted as the Rapporteur and drafting group member for CAT guidelines. Christiane was actively involved in the MHRA's Brexit preparations and has in-depth knowledge of the MHRA no-deal provisions.

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 recently left the public sector to become an independent regulatory consultant.

Christiane Niederlaender's Network

Agenda Sessions

  • Breakfast Surgery – FDA, EMA and PMDA Pinch Points

    , 09:00