Ellie Handy advises clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ms. Handy’s practice focuses on providing life sciences regulatory advice, primarily to pharmaceutical companies and medical device manufacturers. This includes advice on classification, data protection, clinical research, labelling and promotion, and reporting obligations. Ms. Handy also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues.

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI