Ciara Farrell

Ciara is a regulatory and compliance lawyer whose practice focuses on advising pharmaceutical, medical device, cosmetics and food companies on EU and Irish regulatory and compliance issues.
  • Ciara Farrell
  • SENIOR ASSOCIATE, REGULATORY & COMPLIANCE
  • +353 1 920 1427
  • Arthur Cox, Ten Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Expertise

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.

Experience

Recent experience includes advising:

  • a market-leading medical devices company on the regulation and accreditation of medical devices in Ireland, and on the packaging and labelling requirements.
  • in relation to the import, sale and distribution of a food supplement in Ireland.
  • a leading medical device manufacturer in challenging a notified body decision not to renew the CE Certificate of Conformity for their medical device.
  • a startup online medical platform on all aspects of developing its product from healthcare regulation through to data protection and commercial advice.
  • in relation to disclosure of payments to healthcare professionals and healthcare organisations and other related transparency requirements.
  • a global food nutrition company on dairy product labelling requirements.
  • the promotional and non-promotional review board of a global biotech company on all aspects of compliance and ethics.
  • manufacturers, brokers and wholesalers of medicinal products on their registration requirements and their obligations in relation to the licensing, importation and distribution of medicinal products.
  • on all aspects of reimbursement of medicinal products under the IPHA/HSE Agreements, including advice in relation to applications under the Hi-Tech Scheme and challenges to the reimbursement framework.
  • companies set up and establish food business operations in Ireland and guiding them through various regulatory requirements from HACCP management to FSAI registration and inspection.
  • academic and non-academic sponsors of clinical trials in relation to the establishment of their clinical trial programme in Ireland;
  • on the regulatory and compliance aspects of mergers, acquisitions and reorganisations, including conducting due diligence.

Memberships

Ciara is an affiliate member of the Irish Pharmaceutical Healthcare Association and is an active member of the Irish MedTech Association Code of Ethics Steering Committee.

Publications and Speaking Engagements

  • “Practical Implications of the New Clinical Trial Regulation on Disclosure and Data Privacy” – C5 EU Pharmaceutical Regulatory Law Conference London, 2016
  • “Social media and pharmaceutical advertising” – IPHA Legal Seminar Dublin, 2016
  • “The Life Sciences Law Review” – Ireland Chapter
  • “ICLG’s Guide to Pharmaceutical Advertising” – Ireland Chapter
  • “Practical Law Global Guides Medicinal product regulation and product liability in Ireland”- overview
  • “Food and Drug Law and Regulation – Food and Drug regulation in the EU”, Third Edition, FDLI
  • “The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials” – Compliance Online webinar, 2015
  • “Making sense of clinical trial data disclosure in the EU” – Scrip Regulatory Affairs

Publications