Nick Lee
HPRA
Executive Pharmaceutical Assessor
A highly experienced and skilled professional who has worked in R&D, Technical Development/Pharmaceutical Sciences and Regulatory Affairs.
I am currently working in the HPRA in a leadership role, where I am the IE delegate to the EMA QWP. I am the HPRA Lead for Device-Drug Consultations and for Continuous Manufacturing, being the EC/Europe Topic Lead for Continuous Manufacturing and a member of the ICH Q13 EWG.
In-depth knowledge and experience of EU regulatory procedures for both medicinal products and drug-device combination products, coupled with experience of ex-EU procedures for medicinal products and medical devices. My areas of interest include novel/advanced modes of manufacturing and control, and impact of Pharma 4.0 and Data Analytics on regulatory science and regulatory expectations.
Extensive technical knowledge relating to the development, manufacture and control of medicinal products and medical devices, including matrices of biological origin.
Proven leadership capability in a range of professional, multidisciplinary and international domains, with excellent interpersonal and motivational skills.
I am currently working in the HPRA in a leadership role, where I am the IE delegate to the EMA QWP. I am the HPRA Lead for Device-Drug Consultations and for Continuous Manufacturing, being the EC/Europe Topic Lead for Continuous Manufacturing and a member of the ICH Q13 EWG.
In-depth knowledge and experience of EU regulatory procedures for both medicinal products and drug-device combination products, coupled with experience of ex-EU procedures for medicinal products and medical devices. My areas of interest include novel/advanced modes of manufacturing and control, and impact of Pharma 4.0 and Data Analytics on regulatory science and regulatory expectations.
Extensive technical knowledge relating to the development, manufacture and control of medicinal products and medical devices, including matrices of biological origin.
Proven leadership capability in a range of professional, multidisciplinary and international domains, with excellent interpersonal and motivational skills.