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Biological Safety Manager
Michelle is the Biological Safety Manager for the Devices Division at MHRA. She has overall responsibility for the conduct and outcome of biological safety assessments undertaken for clinical investigation notifications submitted to the UK medical device Competent Authority. She also leads on all toxicological projects and investigations undertaken by the Devices Division. She is currently leading the toxicological decision-making process for devices submitted to the UK government under the “fast-track approval of medical devices during COVID-19 process”. She is responsible for developing the minimally acceptable biological safety requirements for the air pathway of a rapidly manufactured ventilator published on the government website at the start of the pandemic. She is currently the chair of CH/194, the committee representing UK in the development of standards for biological safety and clinical evaluation.
Sophie is a Biocompatibility Specialist working as part of the Biological Safety team under the Devices Division at the Medicines and Healthcare products Regulatory Agency (MHRA). She is responsible for assessing biological safety evaluations and toxicological risk assessments according to ISO 10993 and the regulations. Her role includes investigating toxicological signals associated with the use of medical devices. She has achieved a BSc (Hons) Biochemistry and is working towards an MSc in Medical Toxicology. She is also part a committee member for CH/194 ISO 10993.
After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996. I am a European Registered Toxicologist and a Fellow of the British Toxicology Society. I am also a Chartered Biologist and a Fellow of the Royal Society of Biology.
My current role principally involves assessing nonclinical data for Clinical Trial Authorisation (CTA) Applications and Marketing Authorisation Applications (MAA), both for non-biological and biological products, including advanced therapy medicinal products (ATMPs). A further aspect of my job is to offer scientific advice to companies on behalf of the MHRA.
I represented the EU in the ICH revision of the M3 Guideline, on the ICH S10 Guideline, on the Q&A document for ICH S3 (Toxicokinetics) guideline and on the ICH S11 (Nonclinical Studies to Support Paediatric Medicine) guideline.
I work closely with the UK’s National Centre for 3Rs (NC3Rs) and represent the MHRA on a Governmental body dealing with animal welfare. I am also a guest lecturer at the University of Surrey, the University of Hertford and the University of Leicester and a frequent presenter at conferences around the world.
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