Nick Lee, PhD

Nick has a PhD in physico-organic chemistry, and he started his career in Industry developing and implementing NIR applications in primary and secondary manufacturing. Since then, Nick has been involved in a number of organisations in different sectors (originator-generics-CRO; medical device-combination products-medicinals), in increasingly senior roles, culminating as Director of R&D for a small biotechnology company in Ireland. In his role at the HPRA, he has responsibility for assessment of many procedure types including CAPs, CTAs and EMA/national Scientific Advice. As well as being HPRA lead for Continuous Manufacturing and departmental lead for Drug-Device Combination products, Nick is currently ICH Q13 EC/Europe Topic Lead and vice-chair of the QWP.