Christiane_Niederlaender

Christiane Niederlaender

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.

Christiane joined Parexel in January 2021 as Vice President Technical for CMC and now works with developers to get advanced therapies into the clinic and to market. Since joining Parexel, Christiane has done substantial amount of work within the US system and has experience of EU, UK and US CMC requirements.


Appearances