The Swiss regulatory framework for pædiatric health research

Détails

ID Serval
serval:BIB_59893923B739
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
The Swiss regulatory framework for pædiatric health research
Périodique
European Journal of Health Law
Auteur(s)
Junod V.
ISSN
0929-0273
Statut éditorial
Publié
Date de publication
2008
Peer-reviewed
Oui
Volume
15
Numéro
2
Pages
183-195
Langue
anglais
Résumé
Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.
Mots-clé
Pharmaceutical regulation, Ethics committees, Data protection, Swiss law, Paediatric studies, Clinical trials, Drug research
Création de la notice
17/08/2009 8:53
Dernière modification de la notice
20/08/2019 14:13
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