Ontology highlight
ABSTRACT:
SUBMITTER: van Doorn E
PROVIDER: S-EPMC4494354 | biostudies-literature | 2015 Apr
REPOSITORIES: biostudies-literature
Vaccines 20150414 2
Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review pro ...[more]