Personal profile
Professional Information
Dr Elaine Harris is a lecturer in TU Dublin's School of Chemical and BioPharmaceutical Sciences with a particular research focus on the areas of Regulatory Science for the life science sector. She has over 25-years of experience in the Life Sciences industry across a range of technical, management, business and consultancy roles. Following a PhD in bio-inorganic chemistry, she worked in the pharmaceutical industry in new product development and technology evaluation. Since establishing her own consultancy company in 2002, Elaine has focused on the pharma, bio-pharma and medical device industries and has provided consultancy services to academics, companies and government agencies in the areas of R&D capacity and capability building. In 2019 she led an EU Commission-funded project “Policy and strategy development in the field of Advanced Therapy Medicinal Products (ATMPs) SRSS/SC2019/110 “. Elaine is a Funded Investigator with CURAM – an SFI-funded research centre for medical device research and a member of the Education and Skills group for the Gene Therapy and Vaccine Manufacturing Forum (https://www.nibrt.ie/atmp/)
Research Interests
Pharmaceutical Sciences, Regulatory Science, ATMPs
Education/Academic qualification
PhD
Award Date: 1 Jan 1997
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Collaborations and top research areas from the last five years
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November 2025 therapeutic delivery: industry update
Harris, E., 2026, In: Therapeutic Delivery. 17, 2, p. 91-97 7 p.Research output: Contribution to journal › Comment/debate
Open Access -
Opportunities and challenges of the use of the hospital exemption in the early-stage development of novel cellular therapies
Harris, E., 22 Jan 2026, Conference: Irish Society for Gene and Cell Therapy Society (ISGCT). 21 p. 016Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review
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Industry update: the latest developments in the field of therapeutic delivery, January 2025
Harris, E., 2025, In: Therapeutic Delivery. 16, 5, p. 407-414 8 p.Research output: Contribution to journal › Comment/debate
Open AccessFile -
May 2025 therapeutic delivery: industry update
Harris, E., 3 Aug 2025, In: Therapeutic Delivery. 16, 8, p. 701-707 7 p.Research output: Contribution to journal › Comment/debate
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September 2024 therapeutic delivery: industry update
Harris, E., 2 Jan 2025, In: Therapeutic Delivery. 16, 1, p. 1-8 8 p.Research output: Contribution to journal › Comment/debate
Open AccessFile
Activities
- 1 Examination
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Enhancing Regulatory Compliance and Safety in Patient Self Care: An Approach to Symptom Checkers, Connected Devices, Autoinjectors and AI-Powered Autoinjectors
Harris, E. (Examiner)
31 Jan 2026Activity: Examination