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Health Products Regulatory Authority
Homepage:
hpra.ie
Alternate name:
An tÚdarás Rialála Táirgí Sláinte
ROR:
05ejjdn16
OpenAlex ID:
I4405266769
Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works
2017
·
Aniello Santoro
, Georgy Genov
, et al.
·
Drug Safety
·
165
PDF
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives
2023
·
Alan G Fraser
, Elisabetta Biasin
, et al.
·
Expert Review of Medical Devices
·
118
PDF
Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective
2021
·
Pekka Kurki
, Sean Barry
, et al.
·
Drugs
·
105
PDF
Regulation of biosimilar medicines and current perspectives on interchangeability and policy
2018
·
J. O’Callaghan
, S. P. Barry
, et al.
·
European Journal of Clinical Pharmacology
·
94
Paediatric Drug Development and Formulation Design—a European Perspective
2016
·
Diana A. Van Riet-Nales
, Piotr Kozarewicz
, et al.
·
AAPS PharmSciTech
·
92
PDF
New medical device regulations: the regulator’s view
2019
·
Tom Melvin
, Marina Torre
·
EFORT Open Reviews
·
84
PDF
Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland
2017
·
Joan O'Callaghan
, Margaret Bermingham
, et al.
·
Regulatory Toxicology and Pharmacology
·
67
PDF
Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision‐Making
2016
·
S Schneeweiss
, H‐G Eichler
, et al.
·
Clinical Pharmacology & Therapeutics
·
67
Potential for prediction of psychosis and bipolar disorder in Child and Adolescent Mental Health Services: a longitudinal register study of all people born in Finland in 1987
2022
·
Ulla Lång
, Hugh Ramsay
, et al.
·
World Psychiatry
·
62
Systematic Review and Meta-analysis: Psychosis Risk in Children and Adolescents With an At-Risk Mental State
2021
·
Ulla Lång
, Kathryn Yates
, et al.
·
Journal of the American Academy of Child & Adolescent Psychiatry
·
61
Interventions to Reduce Adverse Drug Event-Related Outcomes in Older Adults: A Systematic Review and Meta-analysis
2020
·
Sarah Tecklenborg
, Catherine Byrne
, et al.
·
Drugs & Aging
·
52
Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland
2018
·
J. O’Callaghan
, B. T. Griffin
, et al.
·
BioDrugs
·
46
PDF
Real‐World Evidence to Support EU Regulatory Decision Making—Results From a Pilot of Regulatory Use Cases
2024
·
Stefanie Prilla
, Sophie Groeneveld
, et al.
·
Clinical Pharmacology & Therapeutics
·
44
PDF
Communication on Safety of Medicines in Europe: Current Practices and General Practitioners’ Awareness and Preferences
2017
·
On behalf of SCOPE Work Package 6
, Sieta T. de Vries
, et al.
·
Drug Safety
·
43
PDF
A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies
2022
·
Elena Guillen
, Niklas Ekman
, et al.
·
Clinical Pharmacology & Therapeutics
·
42
PDF
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)
2021
·
A G Fraser
, R G H H Nelissen
, et al.
·
European Heart Journal - Quality of Care and Clinical Outcomes
·
37
PDF
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
2023
·
Nadine Kirsch-Stefan
, Elena Guillen
, et al.
·
BioDrugs
·
34
PDF
Cell-Based Therapies for Cardiac Repair: A Meeting Report on Scientific Observations and European Regulatory Viewpoints
2015
·
Martina Schüssler-Lenz
, Claire Beuneu
, et al.
·
European Journal of Heart Failure
·
34
PDF
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)
2021
·
Alan G. Fraser
, Rob G.H.H. Nelissen
, et al.
·
EFORT Open Reviews
·
31
PDF
Clinical Evidence 2030
2025
·
Peter Arlett
, Denise Umuhire
, et al.
·
Clinical Pharmacology & Therapeutics
·
30
PDF
Commentary on the draft revised guideline on the environmental risk assessment of medicinal products for human use
2019
·
Rhys Whomsley
, Susanne Brendler-Schwaab
, et al.
·
Environmental Sciences Europe
·
27
Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study
2018
·
on behalf of SCOPE work package 6
, Sieta T. de Vries
, et al.
·
Drug Safety
·
27
PDF
CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software
2025
·
Frank E. Rademakers
, Elisabetta Biasin
, et al.
·
npj Digital Medicine
·
22
PDF
Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table
2024
·
Stephan Windecker
, Martine Gilard
, et al.
·
European Heart Journal
·
22
PDF
European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children
2023
·
Kathrin Guerlich
, Bernadeta Patro‐Golab
, et al.
·
Acta Paediatrica
·
22
PDF
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Works count:
79
Citation count:
2,464
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