Michelle Kelly

Toxicologist at NAMSA

Speaker

Prior to joining NAMSA in 2021, Michelle worked at the UK Competent Authority, The Medicines and Healthcare products Regulatory Agency (MRHA), for 14 years as head of biological safety. Her overall responsibility focused on the conduct and outcome of biological safety assessments undertaken by the MHRA, including review of clinical investigation applications, assessment of derogation and exceptional use requests, as well as management of major adverse events related to biological safety which carried significant public health implications.

Michelle is currently the chair of the National Committee for the Biological Evaluation of Medical Devices (CH/194). This committee is working at an international level to represent the UK in the development of key horizontal standards, including ISO 10993 series and ISO 14155. This work is striving for a standardized approach to biological and clinical evaluation of medical materials and medical devices. She is also a European-registered Toxicologist.