Compiling with the Regulatory Requirement of the patient engagement process with pediatrics and their caregivers

There is a growing expectation from regulatory agencies for sponsors to provide robust patient experience data that demonstrate the impact their drugs may have on the quality of life for paediatric patients and their caregivers.

This involves meaningful involvement of patients and their caregivers in research priorities, protocol design, and regulatory decision making . means sponsors must start working closely with the patient community, regulators, key opinion leaders and other stakeholders to develop robust methodologies for data collection and analysis, as well as having systems and processes in place to put that into practice. During this workshop we will aim to discuss the regulatory strategy and medical writing aspects of these expectations and some strategies to address these.

Sarah Milner

Dr Sarah Milner is an experienced clinical and regulatory medical writer. Over the last 15+ years, she has provided medical writing, training, and consulting services to the pharmaceutical industry. Sarah has particular interest in the rare disease space, especially in paediatrics, and is a passionate patient advocate.

Francesca Buttigieg

Ms Francesca Buttigieg is an experienced Regulatory Affairs Director with a demonstrated history of working in the pharmaceutical industry, and is skilled in Global Drug Development, Regulatory Requirements, and Regulatory Strategy.