Patrick has been with NDA since 2018, he is an expert in clinical development, strategies, and a specialist in pharmaceutical medicine. With almost 25 years regulatory experience at both national and EU level his in-depth regulatory expertise in rare diseases and other specialty therapeutic areas such as ophthalmology and the interrelated working of EMA’s committees has successfully provided companies with the insight they need to help their development programme succeed.
Patrick is a Lecturer in Drug Information, Pharmacology and Therapeutics, Trinity College Dublin, as well as being a member of the Management Committee of the Course in Pharmaceutical Medicine in Trinity College Dublin.
Key Areas Of Expertise
- 25 years of Regulatory Affairs, including assessment of non-clinical and clinical dossiers of MAA’s in a broad area of therapeutic areas
- Assessment of CTA’s
- Pharmacovigilance, including assessment of PSURs and RMPs
- Rare diseases and orphan drug designation
Before Joining The NDA Advisory Board
Patrick trained as a physician and after several years in clinical practice, worked for a CRO before joining the Irish Regulatory Authority.
Prior to this, he was a Senior Medical Assessor at the Irish Medicines Board, (the Health Products Regulatory Authority), a member of the Committees for Human Medicinal Products Member (previously CPMP) representing Ireland for 17 years, and the Orphan Medicinal Products.
He was also the chairperson of the CHMP ad hoc SmPC working party, the CMD(h) subgroup on SmPC Harmonisation, and of the working Group on Radiopharmaceuticals. Patrick was also a member of the SmPC advisory group.
Recent Publications
Dr Patrick Salmon