Unit manager, Licensing division
Dr Krystyna Fielden is a pharmacist with a PhD in Pharmaceutical Technology. She worked for 9 years in the pharmaceutical industry in R&D, latterly in regulatory affairs and then joined the MRHA (previously MCA) in 1994. Krystyna was a senior pharmaceutical assessor and is presently the Licensing Division PLAT 2 manager (Product Lifecycle Assessment Team) specialising in in topical products: Eye, Ear, Nose and Throat; Dermatology, Respiratory and Endocrine. She has a continued keen interest in variations through provision of training for assessors, auditing and as a member of the MHRA’s “Variations Assessment Board” advising companies on groupings and classification of changes. Krystyna is a member of MHRA’s Medicines Industry Liaison Group - leading on an initiative to facilitate grouping of variations from which the CCC initiative developed.
The MHRA has established the MHRA Medicines Industry Liaison Group (MLG) in order to work co-operatively with industry in our burden reduction/simplification programme.