Spiros Vamvakas

European Medicines Agency — Netherlands

Economics, Econometrics and Finance · Social Sciences

36h-index4.0kcitations91works7.32yr avg
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Research Topics

Health Systems, Economic Evaluations, Quality of Life(32), Carcinogens and Genotoxicity Assessment(15), Pharmaceutical Economics and Policy(15), Statistical Methods in Clinical Trials(12), Biosimilars and Bioanalytical Methods(12)

Publications91 total

A Fast Path from Innovation to Safe and Effective Medicines
Clinical Pharmacology & Therapeutics·2025Open Access
Clinical Evidence 2030
Clinical Pharmacology & Therapeutics·2025· 18 citedOpen Access
Challenges and ongoing initiatives towards better integrated EU scientific advice
Frontiers in Medicine·2025· 4 citedOpen Access
Patient‐reported, observer‐reported and performance outcomes in qualification procedures at the European Medicines Agency 2013–2018
British Journal of Clinical Pharmacology·2023· 2 citedOpen Access
Biomarker‐Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union
Clinical Pharmacology & Therapeutics·2023· 16 citedOpen Access
Therapeutic Innovations in Neuroscience: What’s New on the Horizon?
Clinical Pharmacology & Therapeutics·2022· 2 citedOpen Access
The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study
Frontiers in Medicine·2022· 41 citedOpen Access
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth
Clinical Pharmacology & Therapeutics·2020· 183 citedOpen Access
Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
Clinical Pharmacology & Therapeutics·2020· 33 citedOpen Access
Digital technologies for medicines: shaping a framework for success
Nature Reviews Drug Discovery·2020· 42 cited
Data Science in Clinical Pharmacology and Drug Development for Improving Health Outcomes in Patients
Clinical Pharmacology & Therapeutics·2020· 8 citedOpen Access
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines
British Journal of Clinical Pharmacology·2020· 36 citedOpen Access
Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia
Clinical Pharmacology & Therapeutics·2019· 54 citedOpen Access
Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation
Clinical Pharmacology & Therapeutics·2019· 66 citedOpen Access
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease
Journal of Parkinson s Disease·2019· 7 citedOpen Access
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease
Journal of Parkinson s Disease·2019· 43 citedOpen Access
Multistakeholder Advice at the European Medicines Agency: Is It Still Needed?
Clinical Pharmacology & Therapeutics·2019· 8 cited
The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations
British Journal of Clinical Pharmacology·2018· 37 citedOpen Access
Marketing authorisation of orphan medicines in Europe from 2000 to 2013
Drug Discovery Today·2017· 32 citedOpen Access
Diagnostic biomarkers for Alzheimer's disease: a regulatory view
The Lancet Neurology·2017· 10 cited
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Frequent Co-authors

Maria Isaac(8), A. Heidland(8), Guido Rasi(6), Francesco Pignatti(5), Hans‐Georg Eichler(5), Robert Hemmings(5), W. Dekant(5), Udo Bahner(4), Luca Pani(4), Franz Koenig(4), Hong Ling(4), Peter Arlett(3), Jan Regnström(3), B. Aronsson(3), D. Henschler(3), Bertil Jönsson(3), Diane Stephenson(3), Harald Enzmann(3), Frank Pétavy(3), Bruno Sepodes(3)