Emma Harvey is an independent consultant in Medical Affairs, specialising in orphan diseases and specialised medicines. She is a specialist pharmaceutical physician, with a Licence to Practise from the GMC. She is a Member of the Royal College of Physicians and a Fellow of the Faculty of Pharmaceutical Medicine. Emma spent 3 years at Alexion Pharma UK as Senior Medical Director where she represented the company at NICE meetings for 2 highly specialised technology appraisals and also represented the company at the first ever appeal against a NICE FED. Emma lead the discussions with key stakeholders, including clinicians, patient advocacy groups and NHS England, to create Managed Access Agreements for two orphan diseases, which were pivotal in ensuring reimbursement through NICE. Since becoming independent Emma has helped advise other orphan disease companies on the creation of Managed Access Agreements and the points to consider to ensure internal company alignment, data collection and stakeholder engagement and approval.