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Christiane Niederlaender

Parexel International, United Kingdom
Vice President, Technical
Christiane is a member of Parexel’s Cell and Gene Therapy Center of Excellence. As VP technical for CMC, her focus is on manufacturing consideration for advanced therapies of all types, including genetically modified cells and viral vectors. Christiane has spent over 12 years in regulatory agencies covering medicines, tissue, cell and gene therapy regulation. She was Unit Manager of the Biologicals Unit and a Senior Quality Assessor and UK delegate at the EMA committee for advanced therapies (CAT) where she was responsible for managing the portfolio of all UK ATMP products and also the Rapporteur for the EMA CAT Gene Therapy Guideline. She has experience with the EU, UK and US regulatory system.

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