Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union
Objective: The purpose of this article is to give an overview of the complexities and unexpected regulatory requirements for obtaining approval of multinational and multicentre non-interventional studies (NIS) in the European Union (EU).Methods: The websites of national competent authorities (CAs),...
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| Format: | Article |
| Language: | deu |
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German Medical Science GMS Publishing House
2015-11-01
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| Series: | GMS German Medical Science |
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| Online Access: | http://www.egms.de/static/en/journals/gms/2015-13/000225.shtml |