Ciara is a regulatory and compliance lawyer whose practice focuses on advising pharmaceutical, medical device, cosmetics, food and agribusiness companies. Ciara regularly advises on both general and sector-specific EU and national requirements in relation to a wide range of products. Ciara has specialist expertise in advising on a wide range of safety, regulatory, compliance and commercial issues that arise throughout the product life cycle from clinical research, borderline classification, digital health, manufacturing, distribution and supply arrangements, authorisation, advertising and labelling, data protection and pricing and reimbursement.
Ciara has valuable in-house compliance experience with a global biotechnology company and sits on the Irish MedTech Association Code of Ethics Steering Committee which gives her valuable experience on complex compliance matters in the pharmaceutical and medical devices sectors. Ciara has also worked with the European Commission which gives her a unique insight of the EU regulatory regime which compliments her work.
Ciara regularly challenges decisions by competent authorities and deals with both contentious and non-contentious matters involving regulatory authorities. She also assists companies in effectively managing their pricing and reimbursement approval process in Ireland.
Ciara regularly speaks at leading life sciences conferences and contributes to articles and publications in this area. Ciara is also an associate member of the Irish Pharmaceutical Healthcare Association and is an active member of the Irish MedTech Association Code of Ethics Steering Committee.