In addition to my professional career as a regulatory lawyer, I also hold a Bachelor of Science degree, BSc (Hons) in Clinical Dietetics from Trinity College Dublin and a Master of Science, MSc (Hons) in Regulatory Affairs.
I also enjoy my additional current position as a visiting Professor in regulatory affairs at the department of health and life sciences at Ulster University, which requires me to keep up to date with regulatory changes and share knowledge with students.
Previously, I have worked in private practice and in house for life sciences companies, which has afforded me a wealth of insight into the practical regulatory challenges, which the industry faces on a daily basis.
Working across the UK and European Fieldfisher teams, I specialise in advising clients on cross border regulatory matters in the medical device, pharmaceutical, biotechnology, veterinary, and healthcare sectors.
My clients range from small and medium sized companies, clinical research organisations to top 100 global life sciences & healthcare companies and academic institutions.
I also hold over a decade of experience as a hospital Clinical Dietitian Manager. My areas of clinical specialism were patient intravenous and enteral tube feeding. I have enjoyed the honour of being appointed by the Irish Minister of Health to the Government State Board - CORU that regulates Health and Social Care Professionals.
I have previously published a book titled “A Guide to European Pharmaceutical Regulations for Human Medicines” which discusses the various life cycle stages in a medicines development and authorisation.
- Advising on QMS GxP compliance standards such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Distribution Practice (GDP) as well as clinical trials and pharmacovigilance regulatory obligations;
- Advising on digital health regulatory pathways and compliance requirements;
- Assisting clinical laboratories with regulatory and accreditation requirements;
- Advising on the application and approval of MHRA and EMA medicine marketing authorisations (MA) as well as importation/distribution regulations for licensed and unlicensed medicines;
- Advising on UK/ EU AI legislation for medical devices, CE/UKCA Mark Certification, Responsible Person/Authorised Representatives and Qualified Person (QP) requirements;
- Advising on manufacturing, quality, business and supply chain agreements;
- Advising Clinical Research Organisations (CRO) on Clinical Research Agreements and the outsourcing of Clinical Trial testing;
- Representing clients during enforcement proceedings before the EU/UK Regulatory Authorities;
- Advising on pricing and reimbursement requirements for medicines sold in the UK;
- Advising food and beverage clients on labelling, nutrition and health claims, advertising and marketing materials in order to ensure compliance with UK/EU Food Regulations and guidelines.
What others say…
Cliodhna has been described by clients as first class at solving complex scientific technical issues with a pragmatic approach.