Title
EU policies in personalized medicine-related technologies
Author
TNO Kwaliteit van Leven
Gaisser, S.
Vignola-Gagné, E.
Hüsing, B.
Enzing, C.
van der Valk, T.
Publication year
2009
Abstract
Against the background of a number of first drug-diagnostic co-products developed and introduce into the European market, European decision-makers feel impelled to react and position themselves in the field of personalized medicine. Their reactions cover a broad range, from the analysis of knowledge requirements for market approval to the need for translational activities and the possible contribution of pharmacogenetics to public health. This article summarizes the current positions of European institutions, based on literature review and expert consultation for three items associated with personalized medicine: biobanks, genetic diagnostics and drug-diagnostic co-products, and provides an outlook on requirements for an effective futute European policy on personalized medicine. © 2009 Future Medicine Ltd.
Subject
Biobanks
Clinical utility
Clinical validity
Drug-diagnostic co-development
Effectiveness
European policy
Framework conditions
Genetic diagnostics
Translational research
Europe
Gene expression profiling
Genetic analysis
Genetic risk
Genetic screening
Genetic susceptibility
Genotype
Health care policy
Medical practice
Medical research
Personalized medicine
Pharmacogenetics
Phenotype
Priority journal
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DOI
https://doi.org/10.2217/17410541.6.1.93
TNO identifier
241659
ISSN
1741-0541
Source
Personalized Medicine, 6 (6), 93-102
Document type
article